Therapy of Obesity and Diabetes Mellitus Type 2 (TADIA)

University Medicine Greifswald

Status: Completed

Conditions: Weight Loss; Obesity; Diabetes Type 2

Treatments: Other: Structured weight-loss program

Study type: Interventional

Funder types: Other

Identifiers

NCT02970838

BB62/12a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Intervention

Experimental group

Description:

Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks

Treatment:

Other: Structured weight-loss program