DiaSurg Study - A prospective study for the clinical evaluation of the effect of a gastric bypass on insulin dependent type 2 diabetes mellitus in non-severely obese patients
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00004605
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
An insulin-dependent T2DM for at least 3 months and daily requirement of > 10IE insulin, BMI from 25 to 35 kg/m², HbA1c > 7% and a residual endocrine pancreatic function which was assessed by stimulated C-peptide laboratory tests with a minimum of 1.5 ng/ml.
Patients were excluded from this study if they could not satisfy the inclusion criteria. Moreover, the suspicion of a diabetes mellitus type 1 or autoimmune diabetes prevented study participation. Other exclusion criteria were clinical cardiac disease in stages III and IV according to the classification of the New York Heart Association, and an unstable coronary artery disease, renal failure with a glomerular filtration rate <45ml/min, chronic obstructive pulmonary disease requiring therapy, immunosuppression / glucocorticoids, previous extensive abdominal surgery, pregnancy, addictive disorders, an active malignant tumor within the last 10 years, pituitary disease (Addison's disease), and a lack of their own capacity to consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diabetes remission after RYGB.<br>Determination by blood samples (fasting glucose, HbA1c) and medical treatment
- Secondary Outcome Measures
Name Time Method The reduction of comorbidities such as hypertension and dyslipidemia is determined by the measurement of blood pressure, medication history and the level of the blood lipids.<br>The reduction of comorbidities such as neuropathy is evaluated through questionnaires (neuropathy symptom score, neuropathy deficit score) and the course of nephropathy is determined by blood tests (creatinine, urea, glomerular filtration rate). In addition a cost-benefit analysis is conducted.