NCT02970838

Therapy of Obesity and Diabetes Mellitus Type 2

Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Diabetes Type 2
• Weight Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2016-11-22
• Last updated: 2016-11-22

Locations

1 site across 1 country: Germany