<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/NCT03832933</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002928</org_study_id>
    <nct_id>NCT03832933</nct_id>
  </id_info>
  <brief_title>Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes</brief_title>
  <official_title>Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes</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 this study is to examine the impact of high protein (HP) vs. normal protein&#xD;
      (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes&#xD;
      (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity&#xD;
      guidance through a group-based weight loss program, State of Slim (SOS). The central&#xD;
      hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater&#xD;
      remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain&#xD;
      and 2) preferentially reducing fat mass while preserving FFM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">April 22, 2022</completion_date>
  <primary_completion_date type="Actual">April 22, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight by weight scale</measure>
    <time_frame>Baseline to 16 weeks</time_frame>
    <description>Participant body weights will be measured on a kg scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body weight by weight scale</measure>
    <time_frame>Baseline to 52 weeks</time_frame>
    <description>Participant body weights will be measured on a kg scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in T2D diagnosis criteria</measure>
    <time_frame>Baseline to 52 weeks.</time_frame>
    <description>T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose &lt;126 mg/dL or hemoglobin A1c &lt;6.5%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in % body fat</measure>
    <time_frame>Baseline to 16 weeks</time_frame>
    <description>Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in % body fat</measure>
    <time_frame>Baseline to 52 weeks.</time_frame>
    <description>Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in % fat free mass (FFM)</measure>
    <time_frame>Baseline to 16 weeks.</time_frame>
    <description>Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in % FFM</measure>
    <time_frame>Baseline to 52 weeks.</time_frame>
    <description>Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Diabetes Type 2</condition>
  <condition>Obesity</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>High Protein Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Protein Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Protein Diet</intervention_name>
    <description>16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.</description>
    <arm_group_label>High Protein Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Protein Diet</intervention_name>
    <description>16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.</description>
    <arm_group_label>Standard Protein Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  T2D diagnosis within previous 6 years (documented physician diagnosis, use of&#xD;
             antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%)&#xD;
&#xD;
          -  BMI of ≥27 kg/m2&#xD;
&#xD;
          -  Weight stable (±3kg in the last 3 months)&#xD;
&#xD;
          -  Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months)&#xD;
             medication dosage and not be planning to change medication dosage&#xD;
&#xD;
          -  Willing and able to participate in a weekly group class for the first 16 weeks of the&#xD;
             study, bi-weekly classes for the remainder of the study, and willing to participate in&#xD;
             4 study visits over the 52 week study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HbA1c concentration of ≥12%.&#xD;
&#xD;
          -  Pregnant or lactating within the past 6 months or trying to become pregnant.&#xD;
&#xD;
          -  Individuals following a vegetarian/vegan only diet&#xD;
&#xD;
          -  Food allergies (to red meats or other common protein sources)&#xD;
&#xD;
          -  Using exogenous insulin for T2D management&#xD;
&#xD;
          -  Taking other medications that could cause weight loss or weight gain (such as&#xD;
             steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC&#xD;
             weight loss agents). Oral contraceptives can be used as long as subject agrees to not&#xD;
             change use of these during the study. Vitamins and minerals that do not have a weight&#xD;
             effect are allowed as long as use is continued without change during the study.&#xD;
&#xD;
          -  Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the&#xD;
             last 6 months will be excluded. Smokers whose smoking habits have been stable for the&#xD;
             last 6 months and which remain stable during the study can be included).&#xD;
&#xD;
          -  Current Eating disorder (anorexia or bulimia)&#xD;
&#xD;
          -  Any medical condition for which following a high protein diet and/or 70 minutes of&#xD;
             exercise daily would be inadvisable.&#xD;
&#xD;
          -  Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least&#xD;
             3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Hill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 7, 2022</last_update_submitted>
  <last_update_submitted_qc>May 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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>James O. Hill</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>weight loss</keyword>
  <keyword>dietary protein</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>No</sharing_ipd>
  </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/NCT03832933
org study id: IRB-300002928
nct id: NCT03832933
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the impact of high protein (HP) vs. normal protein
      (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes
      (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity
      guidance through a group-based weight loss program, State of Slim (SOS). The central
      hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater
      remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain
      and 2) preferentially reducing fat mass while preserving FFM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in body weight by weight scale
time frame: Baseline to 16 weeks
description: Participant body weights will be measured on a kg scale
measure: Change in body weight by weight scale
time frame: Baseline to 52 weeks
description: Participant body weights will be measured on a kg scale
measure: Change in T2D diagnosis criteria
time frame: Baseline to 52 weeks.
description: T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose <126 mg/dL or hemoglobin A1c <6.5%.
measure: Change in % body fat
time frame: Baseline to 16 weeks
description: Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
measure: Change in % body fat
time frame: Baseline to 52 weeks.
description: Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
measure: Change in % fat free mass (FFM)
time frame: Baseline to 16 weeks.
description: Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
measure: Change in % FFM
time frame: Baseline to 52 weeks.
description: Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
arm group label: High Protein Diet
arm group type: Experimental
arm group label: Standard Protein Diet
arm group type: Active Comparator
intervention type: Behavioral
intervention name: High Protein Diet
description: 16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
arm group label: High Protein Diet
intervention type: Behavioral
intervention name: Standard Protein Diet
description: 16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.
arm group label: Standard Protein Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Hill, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: James O. Hill
investigator title: Primary Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No