<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02987335</url>
  </required_header>
  <id_info>
    <org_study_id>2013-2191</org_study_id>
    <secondary_id>R01DK079974</secondary_id>
    <secondary_id>R01DK069861</secondary_id>
    <nct_id>NCT02987335</nct_id>
  </id_info>
  <brief_title>Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States</brief_title>
  <official_title>Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This purpose of this study is to define the metabolic characteristics of individuals with&#xD;
      Lean Diabetes. We aim to determine whether differences in body composition, including any&#xD;
      differences in lipid (fat) deposition, exist compared to individuals with either known forms&#xD;
      of diabetes (eg, type 1 and type 2), or individuals without diabetes. Diabetes affects the&#xD;
      ability of the body to process glucose (sugar). Therefore, we also plan to investigate the&#xD;
      ability of the hormone insulin to regulate changes in glucose in these individuals.&#xD;
      Developing a greater understanding of the features of this condition could have tremendous&#xD;
      therapeutic benefit for these individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030.&#xD;
      This includes many patients with Lean Diabetes, which is a form of diabetes identified&#xD;
      clinically by early onset, high insulin requirements, absence of other pancreatic disease,&#xD;
      and low body mass index (typically ≤17 kg/m2) at presentation. Despite its prevalence, Lean&#xD;
      Diabetes remains a relatively unknown disease that stirs conflicting opinions regarding its&#xD;
      classification, diagnostic criteria, and pathogenesis.&#xD;
&#xD;
      In this study, the investigators will study individuals meeting the criteria for Lean&#xD;
      Diabetes, Type 1 diabetes, Type 2 diabetes, and two group of participants without diabetes&#xD;
      using a procedure called a &quot;pancreatic clamp&quot; study. During the clamp procedure, glucose (a&#xD;
      sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose&#xD;
      in the blood) are infused with an intravenous catheter, and blood samples are collected&#xD;
      periodically throughout the procedure to measure blood sugar levels and the levels of several&#xD;
      hormones that are found in the body and are related to glucose metabolism. Endogenous glucose&#xD;
      production (a measure of the body's production of sugar) will also be measured. Participants&#xD;
      will also have a fat biopsy, and will be given a mixed meal challenge which is a test that&#xD;
      detects hyperglycemia and glucose intolerance.&#xD;
&#xD;
      The overall goal of this study is to define the metabolic characteristics of individuals with&#xD;
      Lean Diabetes and to determine which differences exist compared to individuals with other&#xD;
      known forms of diabetes or individuals without diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2010</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Endogenous Glucose Production</measure>
    <time_frame>120 min to 240 min</time_frame>
    <description>Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Glucose Disposal (RD).</measure>
    <time_frame>240 min to 360 min</time_frame>
    <description>Peripheral Insulin Sensitivity (RD) measured by the change in Glucose Rates of Disappearance in each group during the low phase of the pancreatic clamp study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin Secretion</measure>
    <time_frame>0 min to 120 min</time_frame>
    <description>Insulin secretion assessed during a 120min mixed-meal tolerance test (MMTT). Insulin secretion was calculated from the C-peptide deconvolution studies with measurements mg/kg/min using the trapezoidal method.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Malnutrition; Diabetes</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Lean Diabetes Subjects</arm_group_label>
    <description>N=20 subjects with BMI 16-22.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes Mellitus Subjects</arm_group_label>
    <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 1 Diabetes Mellitus Subjects</arm_group_label>
    <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lean Nondiabetic Subjects</arm_group_label>
    <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese Nondiabetic Subjects</arm_group_label>
    <description>N=9 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pancreatic Clamp</intervention_name>
    <description>We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
    <arm_group_label>Lean Diabetes Subjects</arm_group_label>
    <arm_group_label>Type 1 Diabetes Mellitus Subjects</arm_group_label>
    <arm_group_label>Type 2 Diabetes Mellitus Subjects</arm_group_label>
    <other_name>Clamp</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, Fat Biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the community and outpatient practices in India. Diabetes&#xD;
        subjects must meet the following criteria: Age 19-45 years, diabetes duration at least one&#xD;
        year, negative GAD antibodies, &gt;1.0pmol/l C-peptide response to meal, stable and moderate&#xD;
        glycemic control (HbA1c 8-11%), no pancreatic calcification, and not suffering from&#xD;
        complications. Subjects will be otherwise in good health. Non diabetic subjects (ND): BMI&#xD;
        16-22.5kg/m2 (lean ND) and BMI 24.5-29.5 (obese ND), Age 19-45 years and in general good&#xD;
        health, and no family diabetic history. Subjects will be recruited through various means of&#xD;
        community outreach.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19-45 yr&#xD;
&#xD;
          -  Diabetes duration at least one year (for the diabetes groups)&#xD;
&#xD;
          -  BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic&#xD;
             controls); 22.5-27 kg/m2 in individuals with type 2 diabetes&#xD;
&#xD;
          -  Negative GAD antibodies&#xD;
&#xD;
          -  Present (&gt;1.0pmol/l) C-peptide response to Sustacal challenge&#xD;
&#xD;
          -  Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)&#xD;
&#xD;
          -  Able and willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally disabled persons&#xD;
&#xD;
          -  Major psychiatric disorder on medication (excluding successfully treated depression)&#xD;
&#xD;
          -  HIV/AIDS&#xD;
&#xD;
          -  History of any cancer&#xD;
&#xD;
          -  Alcohol or substance abuse or toxin exposure which could be associated with neuropathy&#xD;
&#xD;
          -  Cushing's syndrome&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  Untreated or uncontrolled hypertension&#xD;
&#xD;
          -  Any Chronic illness requiring medication&#xD;
&#xD;
          -  History of bleeding disorder or with a prolonged PT or PTT&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Liver impairment&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meredith Hawkins</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>August 17, 2022</results_first_submitted>
  <results_first_submitted_qc>November 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 6, 2022</results_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein College of Medicine</investigator_affiliation>
    <investigator_full_name>Meredith Hawkins</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Malnutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02987335/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lean Diabetes Subjects</title>
          <description>N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="P2">
          <title>Type 2 Diabetes Mellitus Subjects</title>
          <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="P3">
          <title>Type 1 Diabetes Mellitus Subjects</title>
          <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="P4">
          <title>Lean Nondiabetic Subjects</title>
          <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="P5">
          <title>Obese Nondiabetic Subjects</title>
          <description>N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lean Diabetes Subjects</title>
          <description>N=20 subjects with BMI 16-22.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="B2">
          <title>Type 2 Diabetes Mellitus Subjects</title>
          <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="B3">
          <title>Type 1 Diabetes Mellitus Subjects</title>
          <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="B4">
          <title>Lean Nondiabetic Subjects</title>
          <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp</description>
        </group>
        <group group_id="B5">
          <title>Obese Nondiabetic Subjects</title>
          <description>N=9 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="73"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.5" lower_limit="36.0" upper_limit="42.0"/>
                    <measurement group_id="B2" value="36.2" lower_limit="32.0" upper_limit="41.0"/>
                    <measurement group_id="B3" value="28.0" lower_limit="25.0" upper_limit="34."/>
                    <measurement group_id="B4" value="26.0" lower_limit="24.5" upper_limit="37.0"/>
                    <measurement group_id="B5" value="41.0" lower_limit="40.0" upper_limit="41.0"/>
                    <measurement group_id="B6" value="33.5" lower_limit="24.5" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Race: for consistency, all subjects will be South Indian</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.3" spread="0.2"/>
                    <measurement group_id="B2" value="26.0" spread="0.3"/>
                    <measurement group_id="B3" value="20.5" spread="0.4"/>
                    <measurement group_id="B4" value="19.1" spread="0.6"/>
                    <measurement group_id="B5" value="25.4" spread="0.35"/>
                    <measurement group_id="B6" value="22.1" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Endogenous Glucose Production</title>
        <description>Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.</description>
        <time_frame>120 min to 240 min</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lean Diabetes Subjects</title>
            <description>N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O2">
            <title>Type 2 Diabetes Mellitus Subjects</title>
            <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O3">
            <title>Type 1 Diabetes Mellitus Subjects</title>
            <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O4">
            <title>Lean Nondiabetic Subjects</title>
            <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O5">
            <title>Obese Nondiabetic Subjects</title>
            <description>N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
        </group_list>
        <measure>
          <title>Endogenous Glucose Production</title>
          <description>Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.</description>
          <units>mg/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.1"/>
                    <measurement group_id="O2" value="0.84" spread="0.1"/>
                    <measurement group_id="O3" value="0.6" spread="0.1"/>
                    <measurement group_id="O4" value="0.4" spread="0.1"/>
                    <measurement group_id="O5" value="0.7" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Glucose Disposal (RD).</title>
        <description>Peripheral Insulin Sensitivity (RD) measured by the change in Glucose Rates of Disappearance in each group during the low phase of the pancreatic clamp study.</description>
        <time_frame>240 min to 360 min</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lean Diabetes Subjects</title>
            <description>N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O2">
            <title>Type 2 Diabetes Mellitus Subjects</title>
            <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O3">
            <title>Type 1 Diabetes Mellitus Subjects</title>
            <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O4">
            <title>Lean Nondiabetic Subjects</title>
            <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O5">
            <title>Obese Nondiabetic Subjects</title>
            <description>N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Glucose Disposal (RD).</title>
          <description>Peripheral Insulin Sensitivity (RD) measured by the change in Glucose Rates of Disappearance in each group during the low phase of the pancreatic clamp study.</description>
          <units>mg/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="0.7"/>
                    <measurement group_id="O2" value="4.2" spread="0.5"/>
                    <measurement group_id="O3" value="8.5" spread="0.4"/>
                    <measurement group_id="O4" value="10.8" spread="0.7"/>
                    <measurement group_id="O5" value="7.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insulin Secretion</title>
        <description>Insulin secretion assessed during a 120min mixed-meal tolerance test (MMTT). Insulin secretion was calculated from the C-peptide deconvolution studies with measurements mg/kg/min using the trapezoidal method.</description>
        <time_frame>0 min to 120 min</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lean Diabetes Subjects</title>
            <description>N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O2">
            <title>Type 2 Diabetes Mellitus Subjects</title>
            <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O3">
            <title>Type 1 Diabetes Mellitus Subjects</title>
            <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O4">
            <title>Lean Nondiabetic Subjects</title>
            <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
          <group group_id="O5">
            <title>Obese Nondiabetic Subjects</title>
            <description>N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
          </group>
        </group_list>
        <measure>
          <title>Insulin Secretion</title>
          <description>Insulin secretion assessed during a 120min mixed-meal tolerance test (MMTT). Insulin secretion was calculated from the C-peptide deconvolution studies with measurements mg/kg/min using the trapezoidal method.</description>
          <units>mg/kg/min</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="383.0" lower_limit="199.8" upper_limit="557.3"/>
                    <measurement group_id="O2" value="839.5" lower_limit="609.8" upper_limit="1366.6"/>
                    <measurement group_id="O3" value="0.09" lower_limit="0.09" upper_limit="0.09"/>
                    <measurement group_id="O4" value="591.1" lower_limit="547.1" upper_limit="1260.5"/>
                    <measurement group_id="O5" value="1277.0" lower_limit="1109.0" upper_limit="1599.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 1 month.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Type 2 Diabetes Mellitus Subjects</title>
          <description>N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="E2">
          <title>Lean Diabetes Subjects</title>
          <description>N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="E3">
          <title>Type 1 Diabetes Mellitus Subjects</title>
          <description>N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="E4">
          <title>Lean Nondiabetic Subjects</title>
          <description>N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
        <group group_id="E5">
          <title>Obese Nondiabetic Subjects</title>
          <description>N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp&#xD;
Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Meredith Hawkins</name_or_title>
      <organization>Albert Einstein College of Medicine</organization>
      <phone>718.430.3186</phone>
      <email>meredith.hawkins@einsteinmed.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987335
org study id: 2013-2191
secondary id: R01DK079974
secondary id: R01DK069861
nct id: NCT02987335
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This purpose of this study is to define the metabolic characteristics of individuals with
      Lean Diabetes. We aim to determine whether differences in body composition, including any
      differences in lipid (fat) deposition, exist compared to individuals with either known forms
      of diabetes (eg, type 1 and type 2), or individuals without diabetes. Diabetes affects the
      ability of the body to process glucose (sugar). Therefore, we also plan to investigate the
      ability of the hormone insulin to regulate changes in glucose in these individuals.
      Developing a greater understanding of the features of this condition could have tremendous
      therapeutic benefit for these individuals.
India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030.
      This includes many patients with Lean Diabetes, which is a form of diabetes identified
      clinically by early onset, high insulin requirements, absence of other pancreatic disease,
      and low body mass index (typically ≤17 kg/m2) at presentation. Despite its prevalence, Lean
      Diabetes remains a relatively unknown disease that stirs conflicting opinions regarding its
      classification, diagnostic criteria, and pathogenesis.

      In this study, the investigators will study individuals meeting the criteria for Lean
      Diabetes, Type 1 diabetes, Type 2 diabetes, and two group of participants without diabetes
      using a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a
      sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose
      in the blood) are infused with an intravenous catheter, and blood samples are collected
      periodically throughout the procedure to measure blood sugar levels and the levels of several
      hormones that are found in the body and are related to glucose metabolism. Endogenous glucose
      production (a measure of the body's production of sugar) will also be measured. Participants
      will also have a fat biopsy, and will be given a mixed meal challenge which is a test that
      detects hyperglycemia and glucose intolerance.

      The overall goal of this study is to define the metabolic characteristics of individuals with
      Lean Diabetes and to determine which differences exist compared to individuals with other
      known forms of diabetes or individuals without diabetes.
observational model: Case-Control
time perspective: Prospective
measure: Endogenous Glucose Production
time frame: 120 min to 240 min
description: Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.
measure: Rate of Glucose Disposal (RD).
time frame: 240 min to 360 min
description: Peripheral Insulin Sensitivity (RD) measured by the change in Glucose Rates of Disappearance in each group during the low phase of the pancreatic clamp study.
measure: Insulin Secretion
time frame: 0 min to 120 min
description: Insulin secretion assessed during a 120min mixed-meal tolerance test (MMTT). Insulin secretion was calculated from the C-peptide deconvolution studies with measurements mg/kg/min using the trapezoidal method.
arm group label: Lean Diabetes Subjects
description: N=20 subjects with BMI 16-22.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.
arm group label: Type 2 Diabetes Mellitus Subjects
description: N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp
arm group label: Type 1 Diabetes Mellitus Subjects
description: N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp
arm group label: Lean Nondiabetic Subjects
description: N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp
arm group label: Obese Nondiabetic Subjects
description: N=9 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp
intervention type: Drug
intervention name: Pancreatic Clamp
description: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.
arm group label: Lean Diabetes Subjects
arm group label: Type 1 Diabetes Mellitus Subjects
arm group label: Type 2 Diabetes Mellitus Subjects
other name: Clamp
Plasma, Fat Biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Meredith Hawkins
role: Principal Investigator
affiliation: Albert Einstein College of Medicine
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein College of Medicine
investigator full name: Meredith Hawkins
investigator title: Professor of Medicine
mesh term: Diabetes Mellitus
mesh term: Malnutrition
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 