<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/NCT03231839</url>
  </required_header>
  <id_info>
    <org_study_id>UTubingen4</org_study_id>
    <nct_id>NCT03231839</nct_id>
  </id_info>
  <brief_title>Nutritional Prevention of Diabetes Mellitus Type 2</brief_title>
  <acronym>NUPREDM</acronym>
  <official_title>Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      This study investigates the influence of red meat and fibers on glucose metabolism and body&#xD;
      fat composition in subjects at increased risk for type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk&#xD;
      factors for T2D is solid. However, few intervention studies have been performed in order to&#xD;
      investigate the role of whole-grain intake or the consumption of red meat in glycemic control&#xD;
      and prevention of diabetes, yielding contradicting results. Thus, in order to prove&#xD;
      causality, further identify potential underlying mechanisms and be able to improve lifestyle&#xD;
      modification programs, we performed a randomized, controlled intervention study over six&#xD;
      months. The participants are individuals at increased risk for tyoe 2 diabetes. They were&#xD;
      randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group),&#xD;
      2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in&#xD;
      fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose&#xD;
      tolerance tests, and MRI measurements of body fat composition and iron content in the liver.&#xD;
      In this study, we want to compare the effectiveness of reduced caloric intake only versus&#xD;
      reduced caloric intake with an additional modification of diet composition in terms of red&#xD;
      meat and fiber consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2009</start_date>
  <completion_date type="Actual">July 31, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2012</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>change in glucose metabolism</measure>
    <time_frame>baseline and six months</time_frame>
    <description>glucose metabolism measured during the oral glucose tolerance test (OGTT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin secretion</measure>
    <time_frame>baseline and six months</time_frame>
    <description>Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver fat</measure>
    <time_frame>baseline and six months</time_frame>
    <description>measured by magnetic resonance spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver iron content</measure>
    <time_frame>baseline and six months</time_frame>
    <description>measured by magnetic resonance imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>baseline and six months</time_frame>
    <description>measured by magnetic resonance imaging</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Nutritional and Metabolic Diseases</condition>
  <condition>Liver Fat</condition>
  <condition>Insulin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Caloric restriction (control)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>daily reduction of caloric intake aimed at 400 kcal/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No red meat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increased fiber intake</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caloric restriction</intervention_name>
    <description>After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).</description>
    <arm_group_label>Caloric restriction (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>no red meat</intervention_name>
    <description>After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).</description>
    <arm_group_label>No red meat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increased fiber intake</intervention_name>
    <description>After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).</description>
    <arm_group_label>Increased fiber intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals at a high risk for Type 2 diabetes:&#xD;
&#xD;
          -  positive family history of type 2 diabetes,&#xD;
&#xD;
          -  presence of metabolic syndrome,&#xD;
&#xD;
          -  body mass index (BMI) &gt; 27 kg/m2,&#xD;
&#xD;
          -  diagnosis of impaired glucose tolerance (IGT)&#xD;
&#xD;
          -  previous diagnosis of gestational diabetes diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Main exclusion criteria&#xD;
&#xD;
          -  diagnosis of type 1 or 2 diabetes mellitus&#xD;
&#xD;
          -  BMI &gt;45 kg/m²&#xD;
&#xD;
          -  presence of serious illness such as cardiovascular, malignant or psychiatric disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>andreas fritsche</investigator_full_name>
    <investigator_title>Professor</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>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not allowed by ethics committee</ipd_description>
  </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/NCT03231839
org study id: UTubingen4
nct id: NCT03231839
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the influence of red meat and fibers on glucose metabolism and body
      fat composition in subjects at increased risk for type 2 diabetes.
The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk
      factors for T2D is solid. However, few intervention studies have been performed in order to
      investigate the role of whole-grain intake or the consumption of red meat in glycemic control
      and prevention of diabetes, yielding contradicting results. Thus, in order to prove
      causality, further identify potential underlying mechanisms and be able to improve lifestyle
      modification programs, we performed a randomized, controlled intervention study over six
      months. The participants are individuals at increased risk for tyoe 2 diabetes. They were
      randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group),
      2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in
      fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose
      tolerance tests, and MRI measurements of body fat composition and iron content in the liver.
      In this study, we want to compare the effectiveness of reduced caloric intake only versus
      reduced caloric intake with an additional modification of diet composition in terms of red
      meat and fiber consumption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: change in glucose metabolism
time frame: baseline and six months
description: glucose metabolism measured during the oral glucose tolerance test (OGTT)
measure: Insulin secretion
time frame: baseline and six months
description: Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))
measure: liver fat
time frame: baseline and six months
description: measured by magnetic resonance spectroscopy
measure: liver iron content
time frame: baseline and six months
description: measured by magnetic resonance imaging
measure: body composition
time frame: baseline and six months
description: measured by magnetic resonance imaging
arm group label: Caloric restriction (control)
arm group type: Placebo Comparator
description: daily reduction of caloric intake aimed at 400 kcal/day
arm group label: No red meat
arm group type: Active Comparator
description: daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake
arm group label: Increased fiber intake
arm group type: Active Comparator
description: daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)
intervention type: Behavioral
intervention name: Caloric restriction
description: After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
arm group label: Caloric restriction (control)
intervention type: Behavioral
intervention name: no red meat
description: After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
arm group label: No red meat
intervention type: Behavioral
intervention name: Increased fiber intake
description: After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
arm group label: Increased fiber intake
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: andreas fritsche
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Resistance
mesh term: Metabolic Diseases
sharing ipd: No
ipd description: Not allowed by ethics committee