Therapy of Obesity and Diabetes Mellitus Type 2
- Conditions
- ObesityWeight LossDiabetes Type 2
- Interventions
- Other: Structured weight-loss program
- Registration Number
- NCT02970838
- Lead Sponsor
- University Medicine Greifswald
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- known type 2 diabetes
- body-mass-index between 27 and 45 kg/m²
- treatment with incretin mimetic drugs < 3 month
- pregnancy
- immobilization
- severe heart, liver or renal failure
- dementia
- eating disorder
- alcoholism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Structured weight-loss program Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks
- Primary Outcome Measures
Name Time Method Change in HbA1c value measured at week 0 and 15
- Secondary Outcome Measures
Name Time Method Change in weight measured at week 0, 6 and 15 Change in body-mass-index measured at week 0, 6 and 15 Change in waist circumference measured at week 0, 6 and 15 Change in hip circumference measured at week 0, 6 and 15 Change in body composition measured at week 0, 6 and 15 Body composition will be assessed with bioimpedance
Change in fat fractions of abdominal organs measured at week 0, 6 and 15 Fat fraction of abdominal organs will be assessed with magnet resonance imaging
Change in visceral fat volume measured at week 0, 6 and 15 Visceral fat volume will be assessed with magnet resonance imaging
Change in fasting glucose measured at week 0 and 15 Change in fasting insulin measured at week 0 and 15 Change in triglycerides measured at week 0, 6 and 15 Change in cholesterol measured at week 0, 6 and 15 Change in HDL cholesterol measured at week 0, 6 and 15 Change in LDL cholesterol measured at week 0, 6 and 15 Change in gamma-glutamyl transferase measured at week 0, 6 and 15 Change in alkaline phosphatase measured at week 0, 6 and 15 Change in 25-hydroxy-vitamine d3 measured at week 0 and 15 Change in alanine transaminase measured at week 0, 6 and 15 Change in aspartate transaminase measured at week 0, 6 and 15 Change in uric acid measured at week 0, 6 and 15 Change in 1,25-dihydroxy-vitamine d3 measured at week 0 and 15 Change in plasma calcium measured at week 0 and 15 Change in plasma phosphate measured at week 0 and 15 Change in insulin-like growth factor-1 measured at week 0 and 15 Change in testosterone measured at week 0 and 15 Change in sex hormone-binding globulin measured at week 0 and 15 Change in quality of life measured at week 0 and 15 Quality of life was determined using SF-12
Change in sleep quality measured at week 0 and 15 Sleep quality was determined using the Pittsburgh sleep quality index
Change in diet history measured at week 0 and 15 7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake
Trial Locations
- Locations (1)
University Medicine Greifswald
🇩🇪Greifswald, Germany