E11
Conditions
Interventions
Group 1: laparoscopic Roux-en-Y gastric bypass - gastrojejunostomy and jejunojejunostomy
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes remission after RYGB. Determination by blood samples (fasting glucose, HbA1c) and medical treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Germany
Contacts
Public ContactBeat Müller
Universitätsklinikum Heidelberg Sektion Minimal Invasive CHirurgie
Outcome results
None listed