<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/NCT03281616</url>
  </required_header>
  <id_info>
    <org_study_id>Refine</org_study_id>
    <nct_id>NCT03281616</nct_id>
  </id_info>
  <brief_title>Lifestyle in Turkish-Background Diabetics</brief_title>
  <official_title>Lifestyle Interventions in Turkish-background Patients With Metabolic Syndrome and Diabetes in Germany</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Life-style interventions are indicated in patients with metabolic syndrome and/or&#xD;
      type 2 diabetes. However, cultural differences are substantial confounders to not only&#xD;
      compliance, but also whether or not the interventions are offered in the first place. In&#xD;
      Germany, the large Turkish-background minority has a particularly high incidence of type 2&#xD;
      diabetes, but there is no recorded evidence of a life-style intervention in this patient&#xD;
      group.&#xD;
&#xD;
      Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced&#xD;
      diet, adjusted to individual eating habits and preferences regarding quality and resources of&#xD;
      food in a Turkish-background cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators conducted a prospective, randomized, two-arm parallel study. In both arms,&#xD;
      patients were instructed in a 12-week diet that was reduced by in caloric content by at least&#xD;
      30% based on calorimetric measurements of 24 h resting energy expenditure and estimated&#xD;
      additional expenditures by diet- and activity-induced thermogenesis. Before and after the&#xD;
      diet, anthropometric measures and various MetS-associated blood parameters were determined.&#xD;
&#xD;
      The subjects were not instructed in an exercise program. However, the subjects were advised&#xD;
      on the value of increased physical activity. For additional motivation, effects were tested&#xD;
      by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy&#xD;
      expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom&#xD;
      dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using&#xD;
      accelerometers and assesses daily energy expenditure. For allocation of the subjects, a&#xD;
      computer-generated list of random numbers was used. The randomization sequence was created&#xD;
      using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned&#xD;
      to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of&#xD;
      2, 4, and 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">September 30, 2015</completion_date>
  <primary_completion_date type="Actual">June 30, 2015</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>Body weight reduction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in body weight (kg) within 12 weeks of diet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in blood glucose (mmol/L) within 12 weeks of diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in blood glycated hemoglobin within 12 weeks of diet</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Diet and Physical Activity Recording</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet and No Physical Activity Recording</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry</description>
    <arm_group_label>Diet and No Physical Activity Recording</arm_group_label>
    <arm_group_label>Diet and Physical Activity Recording</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30 - 65 years&#xD;
&#xD;
          -  BMI 30 - 40 kg/m2&#xD;
&#xD;
          -  non-Insulin dependent diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  more than 3 anti-diabetic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Michael Boschmann</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <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/NCT03281616
org study id: Refine
nct id: NCT03281616
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Life-style interventions are indicated in patients with metabolic syndrome and/or
      type 2 diabetes. However, cultural differences are substantial confounders to not only
      compliance, but also whether or not the interventions are offered in the first place. In
      Germany, the large Turkish-background minority has a particularly high incidence of type 2
      diabetes, but there is no recorded evidence of a life-style intervention in this patient
      group.

      Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced
      diet, adjusted to individual eating habits and preferences regarding quality and resources of
      food in a Turkish-background cohort.
The investigators conducted a prospective, randomized, two-arm parallel study. In both arms,
      patients were instructed in a 12-week diet that was reduced by in caloric content by at least
      30% based on calorimetric measurements of 24 h resting energy expenditure and estimated
      additional expenditures by diet- and activity-induced thermogenesis. Before and after the
      diet, anthropometric measures and various MetS-associated blood parameters were determined.

      The subjects were not instructed in an exercise program. However, the subjects were advised
      on the value of increased physical activity. For additional motivation, effects were tested
      by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy
      expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom
      dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using
      accelerometers and assesses daily energy expenditure. For allocation of the subjects, a
      computer-generated list of random numbers was used. The randomization sequence was created
      using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned
      to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of
      2, 4, and 6.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body weight reduction
time frame: 12 weeks
description: Changes in body weight (kg) within 12 weeks of diet
measure: Blood glucose
time frame: 12 weeks
description: Changes in blood glucose (mmol/L) within 12 weeks of diet
measure: Blood HbA1c
time frame: 12 weeks
description: Changes in blood glycated hemoglobin within 12 weeks of diet
arm group label: Diet and Physical Activity Recording
arm group type: Active Comparator
arm group label: Diet and No Physical Activity Recording
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Diet
description: Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry
arm group label: Diet and No Physical Activity Recording
arm group label: Diet and Physical Activity Recording
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Michael Boschmann
investigator title: Physician
sharing ipd: No