<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/NCT03832725</url>
  </required_header>
  <id_info>
    <org_study_id>UTennHSCFS</org_study_id>
    <nct_id>NCT03832725</nct_id>
  </id_info>
  <brief_title>Pathobiology of Remission of Type 2 Diabetes</brief_title>
  <official_title>Pathobiology of Remission of Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>Yes</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>
      We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM&#xD;
      (NT2DM) women and men for 6 months for remission of Type 2 Diabetes. Our long term goal is to&#xD;
      establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in&#xD;
      physicians' clinics and metabolomics predictors for assessment of remission. The overall&#xD;
      objective of this study is to determine if remission of NT2DM can be induced by dietary&#xD;
      manipulation using a HP diet and the pathobiology of this remission. We hypothesize that&#xD;
      NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and&#xD;
      daily menus for compliance. The rationale is the HP diet is palatable for subjects to&#xD;
      continue after the 6 month study and stay in remission using diet plans we provide. We will&#xD;
      compare the effects of the HP vs HC diet on remission. Specific aims of this study are to&#xD;
      determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 month feeding&#xD;
      study and determine: (a)remission of NT2DM to Normal Glucose Tolerance(NGT), (b)weight loss,&#xD;
      (c)improvements in metabolic markers, Cardiovascular Risk Factors(CVR), and inflammation&#xD;
      markers, and epigenetic DNA methylation changes and pathways involved with remission and&#xD;
      metabolomic markers to establish predictive markers of remission of NT2DM. We propose to use&#xD;
      a non-pharmaceutical means (HP diet) for remission of T2DM and weight loss and determine the&#xD;
      pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with&#xD;
      emerging technologies. The proposed research is significant because if we can demonstrate the&#xD;
      HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be&#xD;
      a significant improvement in health risk and medical cost to subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Greater than 30 million people have diabetes. Over time diabetic patients need more and more&#xD;
      medications and develop numerous medical complications. Remission of Type 2 Diabetes (T2DM)&#xD;
      would have profound effects on people with diabetes with respect to overall health&#xD;
      improvement (insulin sensitivity(Si), cardiovascular risk factors(CVR), inflammation markers&#xD;
      (IC)), reduction of retinopathy, nephropathy, neuropathy and reduction in medical costs.&#xD;
      Methods to accomplish this have not yet been determined, however, it is generally accepted&#xD;
      that non-drug methods to treat T2DM is the most cost effective and have the fewest side&#xD;
      effects. The primary risk factor for T2DM is obesity. Our randomized clinical trials&#xD;
      comparing the effects of High Protein (HP) vs High Carbohydrate (HC) weight loss diets in&#xD;
      obese, prediabetic(IGT) women and men where all foods were provided daily for 6 months(mo)&#xD;
      showed that while both diet groups had similar weight loss, 100% of HP diet subjects had&#xD;
      remission from IGT to Normal Glucose Tolerance(NGT), but only 33% of HC diet group had&#xD;
      remission. Also, the HP diet provided greater improvement in Si, CVR, IC, and an increase in&#xD;
      % lean body mass (LBM) compared to the HC diet demonstrating that weight loss is not the only&#xD;
      factor involved in remission. Based on these findings, we now propose to investigate effects&#xD;
      of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 mo. Our&#xD;
      long term goal is to establish a weight loss diet plan for remission of NT2DM which would be&#xD;
      adaptable for use in physicians' clinics and metabolomics predictors for assess-ment of&#xD;
      remission. The overall objective of this study is to determine if remission of NT2DM can be&#xD;
      induced by dietary manipulation using a HP diet and the pathobiology of this remission. We&#xD;
      hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are&#xD;
      provided the food and daily menus for compliance. The rationale is the HP diet is palatable&#xD;
      for subjects to continue after the 6 mo study and stay in remission using diet plans we&#xD;
      provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this&#xD;
      study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 mo&#xD;
      feeding study and determine: (a)remission of NT2DM to NGT, (b)weight loss and LBM&#xD;
      preservation, (c)improvements in metabolic markers, CVRs, IC, epigenetic DNA methylation&#xD;
      changes and pathways involved with remission and metabolomic markers to establish predictive&#xD;
      markers of remission of NT2DM. This study is innovative in that we propose to use a&#xD;
      non-pharmaceutical means (HP diet) for remission of T2DM diabetes and weight loss and&#xD;
      determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the&#xD;
      samples with emerging technologies. The proposed research is significant because if we can&#xD;
      demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic&#xD;
      improvements, it would be a significant improvement in health risk and medical cost to&#xD;
      subjects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized to a macronutrient high protein or high carbohydrate diet provided by the study for weight loss and remission of Type 2 Diabetes</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Subjects or investigators will not know which macronutrient diet (high protein or high carbohydrate) which they are given for the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Remission of Type 2 Diabetes</measure>
    <time_frame>Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes</time_frame>
    <description>Remission of NT2DM to NGT will be determined by the OGTT ( a 75 gm glucose drink given at 0 minutes and then blood drawn to determine the glucose level at 2 hrs). This OGTT will be done at 3 and 6 months with the criteria of fasting glucose &lt;126 mg/l and 2 hour glucose &lt;140 mg/dl. Criteria for improvement from NT2DM to IGT will be fasting blood glucose &lt;126 mg/dl and 2 hour glucose &lt;199 mg/dl. At each weekly visit for food pick up the subject's glucose will be monitored for blood glucose changes from the start of the diet study. If subjects do not have remission of diabetes at 6 months, they will be referred to an endocrinologist for possible pharmacology treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Each subject will be monitored for 6 months while they are on the HP or HC diet</time_frame>
    <description>Determine changes in weight loss changes in inflammation markers such as cytokines, changes in incretins and determine metabolom markers for diagnosis of remission of NT2DM over the 6 months of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Risk Factors (CVR)</measure>
    <time_frame>Each subject will be monitored for 6 months while they are on the HP or HC diet</time_frame>
    <description>Changes in CVR will be determined by changes in blood pressure (systolic/diastolic) from the start of the diet to the end of the 6 month diet study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation markers such as cytokines,</measure>
    <time_frame>Each subject will be monitored for 6 months while they are on the HP or HC diet</time_frame>
    <description>Changes in inflammation markers in the subjects' blood such as cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolom Markers</measure>
    <time_frame>Each subject will be monitored for 6 months while they are on the HP or HC diet</time_frame>
    <description>Changes in Metabolom Markers will be measured to determine changes from the start of the study to the end of the 6 months for possible markers of remission diabetes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Newly Diagnosed Type 2 Diabetes</condition>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>High protein (HP) weight loss diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High carbohydrate (HC) weight loss diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.&#xD;
Intervention with the HC diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Protein (HP) weight loss diet</intervention_name>
    <description>Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HP diet for 6 months with all food provided for weight loss and remission of NT2DM.&#xD;
Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment</description>
    <arm_group_label>High protein (HP) weight loss diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High carbohydrate (HC) weight loss diet</intervention_name>
    <description>Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HC diet for 6 months with all food provided for weight loss and remission of NT2DM.&#xD;
Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment</description>
    <arm_group_label>High carbohydrate (HC) weight loss diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i) Age range 20 yrs to 50 yrs; ii) BMI &gt; 30 kg/m2 to 55kg/m2; iii). Fasting blood glucose&#xD;
        &gt;126 mg/dl and 2 hour glucose &gt;200 mg/dl determined by OGTT; iv). HbA1c &gt; 6.5 % to ≤10%.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i) Proteinuria or elevated serum creatinine (&gt;1.5 mg/dl); ii) Surgical or premature&#xD;
        menopause; iii) liver disease or abnormal liver function tests; iv) T2DM of greater than 2&#xD;
        yrs; v) Thyroid disease with abnormal TSH; vi) Weight &gt; 350 lbs, (due to fit on DXA); vii)&#xD;
        Triglycerides&gt;400 mg/dl or LDL cholesterol &gt;160 mg/dl; viii) SBP&gt;145, DBP&gt;100 mm of Hg; ix)&#xD;
        on medications known to effect lipid or glucose metabolism; x) Pregnancy or become pregnant&#xD;
        in next 6 mo; xi) Weight loss &gt;10% of body weight in last 6 mo; xii)History of cancer &lt;5&#xD;
        yrs or undergoing active treatment; xiii) smoking, xiv)alcohol abuse; xv) having CPAP&#xD;
        treatment. xvi)Subjects with HbA1c &gt;10% will be referred to an endocrinologist for&#xD;
        pharmacological treatment.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frankie B Stentz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frankie B Stentz, PhD</last_name>
    <phone>901-448-5803</phone>
    <email>fstentz@uthsc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frankie B Stentz, PhD</last_name>
      <phone>901-448-5803</phone>
      <email>fstentz@uthsc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Tennessee</investigator_affiliation>
    <investigator_full_name>Frankie Stentz</investigator_full_name>
    <investigator_title>Professor/ Department of Medicine/Endocrinology, Diabetes and Metabolism</investigator_title>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>obesity</keyword>
  <keyword>pathobiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study protocol and informed consent will be shared. Data at the end of the study will be reported. No patient identification will be shared.</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_time_frame>Over the time frame of the study</ipd_time_frame>
    <ipd_access_criteria>contact investigator</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/NCT03832725
org study id: UTennHSCFS
nct id: NCT03832725
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM
      (NT2DM) women and men for 6 months for remission of Type 2 Diabetes. Our long term goal is to
      establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in
      physicians' clinics and metabolomics predictors for assessment of remission. The overall
      objective of this study is to determine if remission of NT2DM can be induced by dietary
      manipulation using a HP diet and the pathobiology of this remission. We hypothesize that
      NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and
      daily menus for compliance. The rationale is the HP diet is palatable for subjects to
      continue after the 6 month study and stay in remission using diet plans we provide. We will
      compare the effects of the HP vs HC diet on remission. Specific aims of this study are to
      determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 month feeding
      study and determine: (a)remission of NT2DM to Normal Glucose Tolerance(NGT), (b)weight loss,
      (c)improvements in metabolic markers, Cardiovascular Risk Factors(CVR), and inflammation
      markers, and epigenetic DNA methylation changes and pathways involved with remission and
      metabolomic markers to establish predictive markers of remission of NT2DM. We propose to use
      a non-pharmaceutical means (HP diet) for remission of T2DM and weight loss and determine the
      pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with
      emerging technologies. The proposed research is significant because if we can demonstrate the
      HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be
      a significant improvement in health risk and medical cost to subjects.
Greater than 30 million people have diabetes. Over time diabetic patients need more and more
      medications and develop numerous medical complications. Remission of Type 2 Diabetes (T2DM)
      would have profound effects on people with diabetes with respect to overall health
      improvement (insulin sensitivity(Si), cardiovascular risk factors(CVR), inflammation markers
      (IC)), reduction of retinopathy, nephropathy, neuropathy and reduction in medical costs.
      Methods to accomplish this have not yet been determined, however, it is generally accepted
      that non-drug methods to treat T2DM is the most cost effective and have the fewest side
      effects. The primary risk factor for T2DM is obesity. Our randomized clinical trials
      comparing the effects of High Protein (HP) vs High Carbohydrate (HC) weight loss diets in
      obese, prediabetic(IGT) women and men where all foods were provided daily for 6 months(mo)
      showed that while both diet groups had similar weight loss, 100% of HP diet subjects had
      remission from IGT to Normal Glucose Tolerance(NGT), but only 33% of HC diet group had
      remission. Also, the HP diet provided greater improvement in Si, CVR, IC, and an increase in
      % lean body mass (LBM) compared to the HC diet demonstrating that weight loss is not the only
      factor involved in remission. Based on these findings, we now propose to investigate effects
      of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 mo. Our
      long term goal is to establish a weight loss diet plan for remission of NT2DM which would be
      adaptable for use in physicians' clinics and metabolomics predictors for assess-ment of
      remission. The overall objective of this study is to determine if remission of NT2DM can be
      induced by dietary manipulation using a HP diet and the pathobiology of this remission. We
      hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are
      provided the food and daily menus for compliance. The rationale is the HP diet is palatable
      for subjects to continue after the 6 mo study and stay in remission using diet plans we
      provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this
      study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 mo
      feeding study and determine: (a)remission of NT2DM to NGT, (b)weight loss and LBM
      preservation, (c)improvements in metabolic markers, CVRs, IC, epigenetic DNA methylation
      changes and pathways involved with remission and metabolomic markers to establish predictive
      markers of remission of NT2DM. This study is innovative in that we propose to use a
      non-pharmaceutical means (HP diet) for remission of T2DM diabetes and weight loss and
      determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the
      samples with emerging technologies. The proposed research is significant because if we can
      demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic
      improvements, it would be a significant improvement in health risk and medical cost to
      subjects
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to a macronutrient high protein or high carbohydrate diet provided by the study for weight loss and remission of Type 2 Diabetes
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: Subjects or investigators will not know which macronutrient diet (high protein or high carbohydrate) which they are given for the study.
measure: Remission of Type 2 Diabetes
time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes
description: Remission of NT2DM to NGT will be determined by the OGTT ( a 75 gm glucose drink given at 0 minutes and then blood drawn to determine the glucose level at 2 hrs). This OGTT will be done at 3 and 6 months with the criteria of fasting glucose <126 mg/l and 2 hour glucose <140 mg/dl. Criteria for improvement from NT2DM to IGT will be fasting blood glucose <126 mg/dl and 2 hour glucose <199 mg/dl. At each weekly visit for food pick up the subject's glucose will be monitored for blood glucose changes from the start of the diet study. If subjects do not have remission of diabetes at 6 months, they will be referred to an endocrinologist for possible pharmacology treatment.
measure: Weight loss
time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
description: Determine changes in weight loss changes in inflammation markers such as cytokines, changes in incretins and determine metabolom markers for diagnosis of remission of NT2DM over the 6 months of the study
measure: Cardiovascular Risk Factors (CVR)
time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
description: Changes in CVR will be determined by changes in blood pressure (systolic/diastolic) from the start of the diet to the end of the 6 month diet study.
measure: Inflammation markers such as cytokines,
time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
description: Changes in inflammation markers in the subjects' blood such as cytokines
measure: Metabolom Markers
time frame: Each subject will be monitored for 6 months while they are on the HP or HC diet
description: Changes in Metabolom Markers will be measured to determine changes from the start of the study to the end of the 6 months for possible markers of remission diabetes
arm group label: High protein (HP) weight loss diet
arm group type: Active Comparator
description: A weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.
arm group label: High carbohydrate (HC) weight loss diet
arm group type: Active Comparator
description: A weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.
Intervention with the HC diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment
intervention type: Other
intervention name: High Protein (HP) weight loss diet
description: Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HP diet for 6 months with all food provided for weight loss and remission of NT2DM.
Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment
arm group label: High protein (HP) weight loss diet
intervention type: Other
intervention name: High carbohydrate (HC) weight loss diet
description: Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HC diet for 6 months with all food provided for weight loss and remission of NT2DM.
Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment
arm group label: High carbohydrate (HC) weight loss diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frankie B Stentz, PhD
role: Principal Investigator
affiliation: University of Tennessee
last name: Frankie B Stentz, PhD
phone: 901-448-5803
email: fstentz@uthsc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Tennessee
investigator full name: Frankie Stentz
investigator title: Professor/ Department of Medicine/Endocrinology, Diabetes and Metabolism
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: Study protocol and informed consent will be shared. Data at the end of the study will be reported. No patient identification will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Over the time frame of the study
ipd access criteria: contact investigator