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Therapy of Obesity and Diabetes Mellitus Type 2 (TADIA)

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ClinicalTrials.gov Identifier: NCT02970838
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Change in HbA1c value [ Time Frame: measured at week 0 and 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • Change in weight [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in body-mass-index [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in waist circumference [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in hip circumference [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in body composition [ Time Frame: measured at week 0, 6 and 15 ]
    Body composition will be assessed with bioimpedance
  • Change in fat fractions of abdominal organs [ Time Frame: measured at week 0, 6 and 15 ]
    Fat fraction of abdominal organs will be assessed with magnet resonance imaging
  • Change in visceral fat volume [ Time Frame: measured at week 0, 6 and 15 ]
    Visceral fat volume will be assessed with magnet resonance imaging
  • Change in fasting glucose [ Time Frame: measured at week 0 and 15 ]
  • Change in fasting insulin [ Time Frame: measured at week 0 and 15 ]
  • Change in triglycerides [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in cholesterol [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in HDL cholesterol [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in LDL cholesterol [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in alanine transaminase [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in aspartate transaminase [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in gamma-glutamyl transferase [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in alkaline phosphatase [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in uric acid [ Time Frame: measured at week 0, 6 and 15 ]
  • Change in 25-hydroxy-vitamine d3 [ Time Frame: measured at week 0 and 15 ]
  • Change in 1,25-dihydroxy-vitamine d3 [ Time Frame: measured at week 0 and 15 ]
  • Change in plasma calcium [ Time Frame: measured at week 0 and 15 ]
  • Change in plasma phosphate [ Time Frame: measured at week 0 and 15 ]
  • Change in insulin-like growth factor-1 [ Time Frame: measured at week 0 and 15 ]
  • Change in testosterone [ Time Frame: measured at week 0 and 15 ]
  • Change in sex hormone-binding globulin [ Time Frame: measured at week 0 and 15 ]
  • Change in quality of life [ Time Frame: measured at week 0 and 15 ]
    Quality of life was determined using SF-12
  • Change in sleep quality [ Time Frame: measured at week 0 and 15 ]
    Sleep quality was determined using the Pittsburgh sleep quality index
  • Change in diet history [ Time Frame: measured at week 0 and 15 ]
    7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapy of Obesity and Diabetes Mellitus Type 2
Official Title  ICMJE Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Diabetes Type 2
  • Weight Loss
Intervention  ICMJE Other: Structured weight-loss program

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.

Other Name: OPTIFAST II Short Program
Study Arms  ICMJE Experimental: Intervention
Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks
Intervention: Other: Structured weight-loss program
Publications * Frost F, Storck LJ, Kacprowski T, Gärtner S, Rühlemann M, Bang C, Franke A, Völker U, Aghdassi AA, Steveling A, Mayerle J, Weiss FU, Homuth G, Lerch MM. A structured weight loss program increases gut microbiota phylogenetic diversity and reduces levels of Collinsella in obese type 2 diabetics: A pilot study. PLoS One. 2019 Jul 18;14(7):e0219489. doi: 10.1371/journal.pone.0219489. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2016)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • known type 2 diabetes
  • body-mass-index between 27 and 45 kg/m²

Exclusion Criteria:

  • treatment with incretin mimetic drugs < 3 month
  • pregnancy
  • immobilization
  • severe heart, liver or renal failure
  • dementia
  • eating disorder
  • alcoholism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970838
Other Study ID Numbers  ICMJE BB62/12a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Medicine Greifswald
Study Sponsor  ICMJE University Medicine Greifswald
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus M Lerch, MD Department of Medicine A, University Medicine Greifswald
PRS Account University Medicine Greifswald
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP