<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/NCT02970838</url>
  </required_header>
  <id_info>
    <org_study_id>BB62/12a</org_study_id>
    <nct_id>NCT02970838</nct_id>
  </id_info>
  <brief_title>Therapy of Obesity and Diabetes Mellitus Type 2</brief_title>
  <acronym>TADIA</acronym>
  <official_title>Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate a standardized weight-loss program as treatment option for obesity and type 2&#xD;
      diabetes, changes in body composition and metabolic control are investigated in obese&#xD;
      patients with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized&#xD;
      weight-loss program (six weeks of formula diet, followed by the reintroduction of regular&#xD;
      food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All&#xD;
      subjects undergo bioelectrical impedance analyses to investigate body composition and magnet&#xD;
      resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time&#xD;
      points: first before the program, then at the end of the six weeks of formula diet and&#xD;
      finally, at the end of the program after 15 weeks. Laboratory data are measured before and&#xD;
      after the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c value</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body-mass-index</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hip circumference</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
    <description>Body composition will be assessed with bioimpedance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat fractions of abdominal organs</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
    <description>Fat fraction of abdominal organs will be assessed with magnet resonance imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in visceral fat volume</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
    <description>Visceral fat volume will be assessed with magnet resonance imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting glucose</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting insulin</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglycerides</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cholesterol</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL cholesterol</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL cholesterol</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alanine transaminase</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in aspartate transaminase</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gamma-glutamyl transferase</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alkaline phosphatase</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in uric acid</measure>
    <time_frame>measured at week 0, 6 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 25-hydroxy-vitamine d3</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 1,25-dihydroxy-vitamine d3</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma calcium</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma phosphate</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin-like growth factor-1</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in testosterone</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sex hormone-binding globulin</measure>
    <time_frame>measured at week 0 and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>measured at week 0 and 15</time_frame>
    <description>Quality of life was determined using SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality</measure>
    <time_frame>measured at week 0 and 15</time_frame>
    <description>Sleep quality was determined using the Pittsburgh sleep quality index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diet history</measure>
    <time_frame>measured at week 0 and 15</time_frame>
    <description>7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes Type 2</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured weight-loss program</intervention_name>
    <description>During the fasting phase, daily consumption consists of five sachets fully replacing normal food and corresponded to an energy content of 800 kcal. This fasting phase is followed by a four-week refeeding phase, during which regular food will be reintroduced and formula diet is gradually replaced until a daily total intake of 1200 kcal is reached. During the last five weeks of the program, energy intake is gradually increased to an individual level between 1200 kcal and 1500 kcal that allowed subjects to keep their weight stable.&#xD;
Once a week participants visit the study center to monitor health status and taking part in supervised exercises and a nutritional and behavioral counseling.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>OPTIFAST II Short Program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  known type 2 diabetes&#xD;
&#xD;
          -  body-mass-index between 27 and 45 kg/m²&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  treatment with incretin mimetic drugs &lt; 3 month&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  immobilization&#xD;
&#xD;
          -  severe heart, liver or renal failure&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  eating disorder&#xD;
&#xD;
          -  alcoholism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus M Lerch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine A, University Medicine Greifswald</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Formula diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Weight Loss</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/NCT02970838
org study id: BB62/12a
nct id: NCT02970838
lead sponsor: 
has dmc: No
To evaluate a standardized weight-loss program as treatment option for obesity and type 2
      diabetes, changes in body composition and metabolic control are investigated in obese
      patients with diabetes.
Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized
      weight-loss program (six weeks of formula diet, followed by the reintroduction of regular
      food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All
      subjects undergo bioelectrical impedance analyses to investigate body composition and magnet
      resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time
      points: first before the program, then at the end of the six weeks of formula diet and
      finally, at the end of the program after 15 weeks. Laboratory data are measured before and
      after the program.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c value
time frame: measured at week 0 and 15
measure: Change in weight
time frame: measured at week 0, 6 and 15
measure: Change in body-mass-index
time frame: measured at week 0, 6 and 15
measure: Change in waist circumference
time frame: measured at week 0, 6 and 15
measure: Change in hip circumference
time frame: measured at week 0, 6 and 15
measure: Change in body composition
time frame: measured at week 0, 6 and 15
description: Body composition will be assessed with bioimpedance
measure: Change in fat fractions of abdominal organs
time frame: measured at week 0, 6 and 15
description: Fat fraction of abdominal organs will be assessed with magnet resonance imaging
measure: Change in visceral fat volume
time frame: measured at week 0, 6 and 15
description: Visceral fat volume will be assessed with magnet resonance imaging
measure: Change in fasting glucose
time frame: measured at week 0 and 15
measure: Change in fasting insulin
time frame: measured at week 0 and 15
measure: Change in triglycerides
time frame: measured at week 0, 6 and 15
measure: Change in cholesterol
time frame: measured at week 0, 6 and 15
measure: Change in HDL cholesterol
time frame: measured at week 0, 6 and 15
measure: Change in LDL cholesterol
time frame: measured at week 0, 6 and 15
measure: Change in alanine transaminase
time frame: measured at week 0, 6 and 15
measure: Change in aspartate transaminase
time frame: measured at week 0, 6 and 15
measure: Change in gamma-glutamyl transferase
time frame: measured at week 0, 6 and 15
measure: Change in alkaline phosphatase
time frame: measured at week 0, 6 and 15
measure: Change in uric acid
time frame: measured at week 0, 6 and 15
measure: Change in 25-hydroxy-vitamine d3
time frame: measured at week 0 and 15
measure: Change in 1,25-dihydroxy-vitamine d3
time frame: measured at week 0 and 15
measure: Change in plasma calcium
time frame: measured at week 0 and 15
measure: Change in plasma phosphate
time frame: measured at week 0 and 15
measure: Change in insulin-like growth factor-1
time frame: measured at week 0 and 15
measure: Change in testosterone
time frame: measured at week 0 and 15
measure: Change in sex hormone-binding globulin
time frame: measured at week 0 and 15
measure: Change in quality of life
time frame: measured at week 0 and 15
description: Quality of life was determined using SF-12
measure: Change in sleep quality
time frame: measured at week 0 and 15
description: Sleep quality was determined using the Pittsburgh sleep quality index
measure: Change in diet history
time frame: measured at week 0 and 15
description: 7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake
arm group label: Intervention
arm group type: Experimental
description: Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks
intervention type: Other
intervention name: Structured weight-loss program
description: During the fasting phase, daily consumption consists of five sachets fully replacing normal food and corresponded to an energy content of 800 kcal. This fasting phase is followed by a four-week refeeding phase, during which regular food will be reintroduced and formula diet is gradually replaced until a daily total intake of 1200 kcal is reached. During the last five weeks of the program, energy intake is gradually increased to an individual level between 1200 kcal and 1500 kcal that allowed subjects to keep their weight stable.
Once a week participants visit the study center to monitor health status and taking part in supervised exercises and a nutritional and behavioral counseling.
arm group label: Intervention
other name: OPTIFAST II Short Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Markus M Lerch, MD
role: Principal Investigator
affiliation: Department of Medicine A, University Medicine Greifswald
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Obesity
mesh term: Diabetes Mellitus, Type 2
mesh term: Weight Loss
sharing ipd: No