Diabetes Type 2, Obesity, Weight Loss
Conditions
Keywords
Formula diet
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.
Interventions
OTHERStructured 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.
Sponsors
University Medicine Greifswald
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c value | measured at week 0 and 15 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in alkaline phosphatase | measured at week 0, 6 and 15 | — |
| Change in uric acid | measured at week 0, 6 and 15 | — |
| Change in 25-hydroxy-vitamine d3 | measured at week 0 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 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 gamma-glutamyl transferase | 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 alanine transaminase | measured at week 0, 6 and 15 | — |
| Change in aspartate transaminase | measured at week 0, 6 and 15 | — |
| 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 |
| Change in hip circumference | measured at week 0, 6 and 15 | — |
Countries
Germany
Outcome results
None listed