<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/NCT02250066</url>
  </required_header>
  <id_info>
    <org_study_id>IlamUMS</org_study_id>
    <nct_id>NCT02250066</nct_id>
  </id_info>
  <brief_title>Prevention of Type 2 Diabetes Mellitus by Changes in Diet</brief_title>
  <official_title>Effect of Diet Therapy on Prevention of Type 2 Diabetes Mellitus Among 322 Adults Over 20 Years With Abnormal Glucose Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ilam University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ilam University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      investigators evaluated the efficacy of two types of diet with different macronutrients, on&#xD;
      prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting&#xD;
      glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were&#xD;
      randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or&#xD;
      control group (n=109) and followed for 2 years. For calculating daily energy requirement in&#xD;
      subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal&#xD;
      body weight with no attempt for losing body weight. Control group were encouraged to follow&#xD;
      the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and&#xD;
      saturated fat to less than 10 percent of total energy. The primary outcome variable was&#xD;
      incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association&#xD;
      criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      322 participants were randomized and stratified into a control group and two study groups&#xD;
      according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were&#xD;
      anthropometric measurements, food diary and laboratory exams. Anthropometric measurements&#xD;
      were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours&#xD;
      after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein&#xD;
      (LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university&#xD;
      hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in&#xD;
      all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body&#xD;
      weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with&#xD;
      use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from&#xD;
      fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from&#xD;
      protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA&#xD;
      in this group was olive oil. In the intervention groups diet regimen was written for each&#xD;
      participant by a registered dietitian. Group three or the control group was encouraged to&#xD;
      follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy&#xD;
      consumption and saturated fat to less than 10 percent of total energy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Diabetes in 322 Subjects with Prediabetes</measure>
    <time_frame>Up to 24 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">322</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Study group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Received high monounsaturated fat diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Received high carbohydrate diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group was encouraged to follow the Food Guide Pyramid</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Study group 1 received high monounsaturated fat diet Study group2 received high carbohydrate diet Control group was encouraged to follow the Food Guide Pyramid</description>
    <arm_group_label>Study group 1</arm_group_label>
    <arm_group_label>Study group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Adults over 20 years Exclusion Criteria: Diet therapy; severe physical&#xD;
        activity; accompanying diseases such as cancer which reduce their life expectancy;&#xD;
        receiving thiazide diuretics; receiving systemic ß blockers; receiving glucocorticoids;&#xD;
        receiving nicotinic acid; receiving weight lowering drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>July 16, 2017</last_update_submitted>
  <last_update_submitted_qc>July 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zahra Vahdat Shariatpanahi</investigator_full_name>
    <investigator_title>Assistant Professor, MD, Ph.D of Nutrition</investigator_title>
  </responsible_party>
  <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/NCT02250066
org study id: IlamUMS
nct id: NCT02250066
lead sponsor: 
has dmc: Yes
investigators evaluated the efficacy of two types of diet with different macronutrients, on
      prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting
      glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were
      randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or
      control group (n=109) and followed for 2 years. For calculating daily energy requirement in
      subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal
      body weight with no attempt for losing body weight. Control group were encouraged to follow
      the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and
      saturated fat to less than 10 percent of total energy. The primary outcome variable was
      incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association
      criteria.
322 participants were randomized and stratified into a control group and two study groups
      according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were
      anthropometric measurements, food diary and laboratory exams. Anthropometric measurements
      were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours
      after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein
      (LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university
      hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in
      all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body
      weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with
      use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from
      fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from
      protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA
      in this group was olive oil. In the intervention groups diet regimen was written for each
      participant by a registered dietitian. Group three or the control group was encouraged to
      follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy
      consumption and saturated fat to less than 10 percent of total energy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of Diabetes in 322 Subjects with Prediabetes
time frame: Up to 24 months
arm group label: Study group 1
arm group type: Other
description: Received high monounsaturated fat diet
arm group label: Study group 2
arm group type: Other
description: Received high carbohydrate diet
arm group label: Control Group
arm group type: No Intervention
description: Control group was encouraged to follow the Food Guide Pyramid
intervention type: Other
intervention name: Diet
description: Study group 1 received high monounsaturated fat diet Study group2 received high carbohydrate diet Control group was encouraged to follow the Food Guide Pyramid
arm group label: Study group 1
arm group label: Study group 2
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Zahra Vahdat Shariatpanahi
investigator title: Assistant Professor, MD, Ph.D of Nutrition
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No