<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/NCT03805633</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300000289</org_study_id>
    <nct_id>NCT03805633</nct_id>
  </id_info>
  <brief_title>A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus</brief_title>
  <official_title>A Suspected Association Between Sarcoidosis and Development of Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the characteristics of patients with diabetes and&#xD;
      sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. The&#xD;
      investigators will approach these aims by measuring hemoglobin A1c, C peptide, insulin&#xD;
      levels, and 2-hour glucose tolerance test results on the study population as well as&#xD;
      collecting clinical data from records. Three groups of patients will be identified from&#xD;
      pulmonary and endocrinology clinics at the University of Alabama at Birmingham. The first&#xD;
      group will have a diagnosis of sarcoidosis without diabetes, the second group will have a&#xD;
      diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of&#xD;
      diabetes without sarcoidosis. Sample size is not pre-determined, but investigators anticipate&#xD;
      this number to be less than 100. These patients will be asked in person during an office&#xD;
      visit to join the study. For each patient who agrees to join, at a clinic visit,&#xD;
      investigators will review and sign consent. Following the visit or at a time convenient for&#xD;
      each patient, study subjects will undergo a fasting plasma venous sample collection for a&#xD;
      hemoglobin A1c, C peptide, insulin level and perform a 2-hour oral glucose tolerance test.&#xD;
      The degree of glucose intolerance and prevalence of diabetes will be analyzed and compared&#xD;
      between the groups and to historical published control data via T test comparisons. At a&#xD;
      later separate visit, patients recruited will undergo ultrasound of the pancreas to assess&#xD;
      pancreatic size and morphology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Person working on the trial left&#xD;
  </why_stopped>
  <start_date type="Actual">February 2, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Change in glucose during oral glucose tolerance test (oGTT)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in C peptide over oGTT</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin response oGTT</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Sarcoidosis</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sarcoidosis Patients</arm_group_label>
    <description>Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes Patients</arm_group_label>
    <description>Patients followed by UAB Endocrinology with diabetes mellitus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sarcoidosis and Diabetes patients</arm_group_label>
    <description>Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Venous blood sample</intervention_name>
    <description>Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.</description>
    <arm_group_label>Diabetes Patients</arm_group_label>
    <arm_group_label>Sarcoidosis Patients</arm_group_label>
    <arm_group_label>Sarcoidosis and Diabetes patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound of pancreas</intervention_name>
    <description>Ultrasound of pancreas will be obtained on all study participants.</description>
    <arm_group_label>Diabetes Patients</arm_group_label>
    <arm_group_label>Sarcoidosis Patients</arm_group_label>
    <arm_group_label>Sarcoidosis and Diabetes patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One group will consist of patients referred to or followed at UAB pulmonary clinic with an&#xD;
        established diagnosis of sarcoidosis without diabetes mellitus. A second group will consist&#xD;
        of patients referred to or followed at UAB pulmonary and/or endocrinology clinic with&#xD;
        diagnoses of both sarcoidosis and diabetes mellitus. A third group will consist of patients&#xD;
        referred to or followed at UAB endocrinology clinic with a diagnosis of diabetes mellitus&#xD;
        without sarcoidosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult patient referred to or followed in UAB pulmonary clinic with an established&#xD;
             diagnosis of sarcoidosis. Any adult patient followed in UAB endocrinology clinic with&#xD;
             a diagnosis of diabetes mellitus (excluding type 1 diabetes).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes and/or chronic use of corticosteroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Fernando Ovalle</investigator_full_name>
    <investigator_title>Medical Doctor, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected individual participant data (IPD)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>starting 1 month after publication</ipd_time_frame>
    <ipd_access_criteria>IPD will be shared with future participating researchers who are not yet identified (future fellow physicians).</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03805633
org study id: IRB-300000289
nct id: NCT03805633
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine the characteristics of patients with diabetes and
      sarcoidosis and to compare them with those of patients with diabetes and no sarcoidosis. The
      investigators will approach these aims by measuring hemoglobin A1c, C peptide, insulin
      levels, and 2-hour glucose tolerance test results on the study population as well as
      collecting clinical data from records. Three groups of patients will be identified from
      pulmonary and endocrinology clinics at the University of Alabama at Birmingham. The first
      group will have a diagnosis of sarcoidosis without diabetes, the second group will have a
      diagnosis of both sarcoidosis and diabetes, and the third group will have a diagnosis of
      diabetes without sarcoidosis. Sample size is not pre-determined, but investigators anticipate
      this number to be less than 100. These patients will be asked in person during an office
      visit to join the study. For each patient who agrees to join, at a clinic visit,
      investigators will review and sign consent. Following the visit or at a time convenient for
      each patient, study subjects will undergo a fasting plasma venous sample collection for a
      hemoglobin A1c, C peptide, insulin level and perform a 2-hour oral glucose tolerance test.
      The degree of glucose intolerance and prevalence of diabetes will be analyzed and compared
      between the groups and to historical published control data via T test comparisons. At a
      later separate visit, patients recruited will undergo ultrasound of the pancreas to assess
      pancreatic size and morphology.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Change in glucose during oral glucose tolerance test (oGTT)
time frame: Baseline
measure: Change in C peptide over oGTT
time frame: Baseline
measure: Change in insulin response oGTT
time frame: Baseline
measure: Hemoglobin A1c (HbA1c)
time frame: Baseline
arm group label: Sarcoidosis Patients
description: Patients referred to UAB Pulmonology who are diagnosed with sarcoidosis.
arm group label: Diabetes Patients
description: Patients followed by UAB Endocrinology with diabetes mellitus.
arm group label: Sarcoidosis and Diabetes patients
description: Patients followed by UAB Pulmonary and/or UAB Endocrinology with both sarcoidosis and diabetes mellitus.
intervention type: Diagnostic Test
intervention name: Venous blood sample
description: Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.
arm group label: Diabetes Patients
arm group label: Sarcoidosis Patients
arm group label: Sarcoidosis and Diabetes patients
intervention type: Diagnostic Test
intervention name: Ultrasound of pancreas
description: Ultrasound of pancreas will be obtained on all study participants.
arm group label: Diabetes Patients
arm group label: Sarcoidosis Patients
arm group label: Sarcoidosis and Diabetes patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Fernando Ovalle
investigator title: Medical Doctor, Professor
mesh term: Sarcoidosis
mesh term: Diabetes Mellitus
mesh term: Pancrelipase
sharing ipd: Yes
ipd description: All collected individual participant data (IPD)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: starting 1 month after publication
ipd access criteria: IPD will be shared with future participating researchers who are not yet identified (future fellow physicians).