<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/NCT03258918</url>
  </required_header>
  <id_info>
    <org_study_id>F046400</org_study_id>
    <nct_id>NCT03258918</nct_id>
  </id_info>
  <brief_title>A Low-Carbohydrate Diabetes Prevention Program</brief_title>
  <official_title>A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Individuals With Prediabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Kidney Foundation of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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 investigators will conduct a single-arm mixed methods pilot study to estimate weight loss&#xD;
      as well as the percentage of participants who achieve 5% weight loss in a 16-week,&#xD;
      Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP&#xD;
      cohort will be compared to weight loss outcomes from previously published DPP studies. The&#xD;
      investigators will also evaluate secondary outcomes including change in physical activity,&#xD;
      mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An estimated 86 million US adults are have prediabetes, and, without intervention, many will&#xD;
      develop T2DM over time. Fortunately, T2DM can be prevented or delayed through modest&#xD;
      lifestyle changes. The landmark Diabetes Prevention Program (DPP) Trial demonstrated a 58&#xD;
      percent reduction in the 3-year incidence of T2DM among individuals with prediabetes who&#xD;
      achieved 7 percent body weight loss and engaged in routine physical activity. Accordingly,&#xD;
      the DPP lifestyle intervention has been translated to communities across the United States,&#xD;
      and, on average, participant weight change is 4 percent at 12 months. Thus, while group-based&#xD;
      DPPs and can effectively promote weight loss among some participants, many DPP participants&#xD;
      do not achieve the program goal of 5 to 7 percent body weight loss.&#xD;
&#xD;
      Novel strategies to help participants achieve DPP weight-loss goals are important for two key&#xD;
      reasons. First, weight loss is the primary driver of T2DM risk reduction, and the potential&#xD;
      population health impact of the intervention is diminished when participants do not lose&#xD;
      weight. Second, a growing number of health plans including Medicare offer coverage for the&#xD;
      DPP and proposed reimbursement is largely tied to weight loss of at least 5 percent at 6&#xD;
      months and 12 months. The DPP costs approximately $400-$500 per participant per year.&#xD;
      Unfortunately, organizations that offer the DPP may be reimbursed for much less than this if&#xD;
      participants do not meet weight loss goals, which could significantly compromise the&#xD;
      program's long-term financial sustainability.&#xD;
&#xD;
      One promising approach to help DPP participants lose more weight may be through a&#xD;
      low-carbohydrate (LC) dietary intervention. Consistent with United States Dietary Guidelines&#xD;
      (USDG), the original DPP Trial and translational group-based curricula recommend a low-fat&#xD;
      (LF), calorie-restricted diet. However, there is growing controversy regarding the scientific&#xD;
      merit of the Dietary Guidelines as well as growing recognition that LC diets may be more&#xD;
      effective than LF diets for short-term weight loss and long-term weight maintenance. Notably,&#xD;
      weight loss occurs without calorie restriction and LC diets improve blood glucose levels&#xD;
      among individuals with T2DM and insulin resistance. Thus, a LC dietary intervention for&#xD;
      prediabetes may augment individual weight loss and T2DM risk reduction while also maximizing&#xD;
      third-party reimbursement.&#xD;
&#xD;
      The aim of this mixed methods pilot study is to test whether a LC-DPP may lead to greater&#xD;
      weight loss than the original DPP. In addition to objective measures of this program's&#xD;
      preliminary efficacy (e.g. weight, HbA1c) the study team will also obtain qualitative&#xD;
      participant feedback on the intervention. Taken together, these data will be used to improve&#xD;
      the curriculum and inform a larger-scale intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">November 7, 2018</completion_date>
  <primary_completion_date type="Actual">November 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight per participant over the study period</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Measured as percent body weight loss per participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants who achieve weight loss goal</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Measured as percentange of participants who achieve 5% total body weight loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported weekly physical activity minutes</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will maintain a log of weekly physical activity minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity measured using the International Physical Activity Questionnaire</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will complete this validated survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food cravings measured using the Control of Eating Questionnaire</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will complete this validated survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stress eating measured using the Palatable Eating Motives Scale</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will complete this validated survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported health measured using the Global Health PROMIS Questionnaire</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will complete this validated survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will complete this validated survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin A1c</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Measured using a laboratory blood draw</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Session attendance</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Measured as the number of sessions attended per participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study attrition</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Number of participants lost to follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in diet as assessed by qualitative review of foods logs</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will maintain weekly food logs</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in diet as assessed by response to survey questions</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will respond to exploratory survey questions about diet created by the study team.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in physical symptoms</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Participants will respond to exploratory survey questions about physical symptoms created by the study team.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Low-Carbohydrate Diabetes Prevention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At least 20 individuals with prediabetes will participate in a year-long , group-based program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low-Carbohydrate Diabetes Prevention Program</intervention_name>
    <description>LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.</description>
    <arm_group_label>Low-Carbohydrate Diabetes Prevention Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Overweight, defined as BMI≥25 kg/m2 [31]&#xD;
&#xD;
          2. HbA1c between 5.7-6.4% drawn within 6 months of the study start date&#xD;
&#xD;
          3. Willingness to participate in group-based classes&#xD;
&#xD;
          4. Able to engage in at least light physical activities such as walking.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. History of type 1 diabetes or type 2 diabetes&#xD;
&#xD;
          2. Current participation in another lifestyle or behavior change program or research&#xD;
             study&#xD;
&#xD;
          3. Vegetarian or vegan lifestyle&#xD;
&#xD;
          4. History of bariatric surgery&#xD;
&#xD;
          5. Inability to read, write, or speak English&#xD;
&#xD;
          6. Inability to provide informed consent&#xD;
&#xD;
          7. Women who are pregnant or intend to become pregnant during the intervention period.&#xD;
&#xD;
          8. Insured by Premier Care or Grad Care; these individuals have the opportunity to&#xD;
             participate in a standard DPP, which is offered as a covered benefit through their&#xD;
             health plan.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Michigan Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Dina Griauzde, Internal Medicine</investigator_full_name>
    <investigator_title>Clinical Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT03258918
org study id: F046400
nct id: NCT03258918
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss
      as well as the percentage of participants who achieve 5% weight loss in a 16-week,
      Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP
      cohort will be compared to weight loss outcomes from previously published DPP studies. The
      investigators will also evaluate secondary outcomes including change in physical activity,
      mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.
An estimated 86 million US adults are have prediabetes, and, without intervention, many will
      develop T2DM over time. Fortunately, T2DM can be prevented or delayed through modest
      lifestyle changes. The landmark Diabetes Prevention Program (DPP) Trial demonstrated a 58
      percent reduction in the 3-year incidence of T2DM among individuals with prediabetes who
      achieved 7 percent body weight loss and engaged in routine physical activity. Accordingly,
      the DPP lifestyle intervention has been translated to communities across the United States,
      and, on average, participant weight change is 4 percent at 12 months. Thus, while group-based
      DPPs and can effectively promote weight loss among some participants, many DPP participants
      do not achieve the program goal of 5 to 7 percent body weight loss.

      Novel strategies to help participants achieve DPP weight-loss goals are important for two key
      reasons. First, weight loss is the primary driver of T2DM risk reduction, and the potential
      population health impact of the intervention is diminished when participants do not lose
      weight. Second, a growing number of health plans including Medicare offer coverage for the
      DPP and proposed reimbursement is largely tied to weight loss of at least 5 percent at 6
      months and 12 months. The DPP costs approximately $400-$500 per participant per year.
      Unfortunately, organizations that offer the DPP may be reimbursed for much less than this if
      participants do not meet weight loss goals, which could significantly compromise the
      program's long-term financial sustainability.

      One promising approach to help DPP participants lose more weight may be through a
      low-carbohydrate (LC) dietary intervention. Consistent with United States Dietary Guidelines
      (USDG), the original DPP Trial and translational group-based curricula recommend a low-fat
      (LF), calorie-restricted diet. However, there is growing controversy regarding the scientific
      merit of the Dietary Guidelines as well as growing recognition that LC diets may be more
      effective than LF diets for short-term weight loss and long-term weight maintenance. Notably,
      weight loss occurs without calorie restriction and LC diets improve blood glucose levels
      among individuals with T2DM and insulin resistance. Thus, a LC dietary intervention for
      prediabetes may augment individual weight loss and T2DM risk reduction while also maximizing
      third-party reimbursement.

      The aim of this mixed methods pilot study is to test whether a LC-DPP may lead to greater
      weight loss than the original DPP. In addition to objective measures of this program's
      preliminary efficacy (e.g. weight, HbA1c) the study team will also obtain qualitative
      participant feedback on the intervention. Taken together, these data will be used to improve
      the curriculum and inform a larger-scale intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in body weight per participant over the study period
time frame: Baseline, 12 months
description: Measured as percent body weight loss per participant
measure: Percentage of participants who achieve weight loss goal
time frame: Baseline,12 months
description: Measured as percentange of participants who achieve 5% total body weight loss
measure: Change in self-reported weekly physical activity minutes
time frame: Baseline, 12 months
description: Participants will maintain a log of weekly physical activity minutes
measure: Change in physical activity measured using the International Physical Activity Questionnaire
time frame: Baseline, 12 months
description: Participants will complete this validated survey
measure: Change in food cravings measured using the Control of Eating Questionnaire
time frame: Baseline, 12 months
description: Participants will complete this validated survey
measure: Change in stress eating measured using the Palatable Eating Motives Scale
time frame: Baseline, 12 months
description: Participants will complete this validated survey
measure: Change in self-reported health measured using the Global Health PROMIS Questionnaire
time frame: Baseline, 12 months
description: Participants will complete this validated survey
measure: Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
time frame: Baseline, 12 months
description: Participants will complete this validated survey
measure: Change in hemoglobin A1c
time frame: Baseline, 12 months
description: Measured using a laboratory blood draw
measure: Session attendance
time frame: Baseline, 12 months
description: Measured as the number of sessions attended per participant
measure: Study attrition
time frame: Baseline, 12 months
description: Number of participants lost to follow-up
measure: Change in diet as assessed by qualitative review of foods logs
time frame: Baseline, 12 months
description: Participants will maintain weekly food logs
measure: Change in diet as assessed by response to survey questions
time frame: Baseline, 12 months
description: Participants will respond to exploratory survey questions about diet created by the study team.
measure: Change in physical symptoms
time frame: Baseline, 12 months
description: Participants will respond to exploratory survey questions about physical symptoms created by the study team.
arm group label: Low-Carbohydrate Diabetes Prevention Program
arm group type: Experimental
description: At least 20 individuals with prediabetes will participate in a year-long , group-based program.
intervention type: Behavioral
intervention name: Low-Carbohydrate Diabetes Prevention Program
description: LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.
arm group label: Low-Carbohydrate Diabetes Prevention Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Dina Griauzde, Internal Medicine
investigator title: Clinical Lecturer
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No