Therapy of Obesity and Diabetes Mellitus Type 2 (TADIA)

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

Tracking Information

• First Submitted Date: November 1, 2016
• First Posted Date: November 22, 2016
• Last Update Posted Date: November 22, 2016
• Study Start Date: November 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 18, 2016): Change in HbA1c value [ Time Frame: measured at week 0 and 15 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Therapy of Obesity and Diabetes Mellitus Type 2
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Obesity
• Diabetes Type 2
• Weight Loss

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 18, 2016): 36
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02970838
• Other Study ID Numbers: BB62/12a
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University Medicine Greifswald
• Study Sponsor: University Medicine Greifswald
• Collaborators: Not Provided

Investigators

• Principal Investigator: Markus M Lerch, MD; Department of Medicine A, University Medicine Greifswald

• PRS Account: University Medicine Greifswald
• Verification Date: November 2016