E11
Conditions
Interventions
Group 1: Laparoscopic Roux-en-Y gastric bypass and standard medical care (S3 guidelines)
Group 2: Optimal medical care according to the national treatment guidelines for type 2 diabetes mellitus
Sponsors
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diagnosis of T2DM with insulin therapy for at least 3 months; Proof of at least one microvascular manifestation of diabetes (e.g., nephropathy, retinopathy, neuropathy); Residual pancreatic function, which is the premise for autogenic glycaemic control assessed by stimulated fasting C-peptide laboratory tests with a minimum of 1.5 ng/ml; HbA1c at least 7%; ASA at least 3; BMI 26–35 kg/m²; Age 30–70 years;; beta cell autoantibody test for patients who recieved insulin therapy in the past year for diabetes mellitus type II; written informed consent; OK from board-certified endocrinologist
Exclusion criteria
Exclusion criteria: Type I diabetes mellitus or latent autoimmune Diabetes in adults (LADA); T2DM on diet and/or oral medication; Heart failure (NYHA III–IV); instable angina pectoris; liver cirrhosis; glucocorticoid or other immunosuppressive therapy; puituitary disease/ M. Addison; renal failure (GFR < 45 ml/min); Pregnancy; malignant disease in the past 5 years (except basalioma); history of major abdominal operation; expected lack of compliance; participation in another interventional study with interference of intervention and outcome; inability to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time from randomization to one of the composite events, including death from cardiovascular causes, non-fatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention, non-fatal stroke, amputation, and surgery for peripheral atherosclerotic artery disease during the follow-up period of eight years . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the time to death from any cause and the time to each component of the primary endpoint. In addition, laboratory parameters for T2DM (HbA1c, C-peptide and glucagon stimulated C-peptide, fasting glucose, fasting insulin, oral glucose tolerance test), regular laboratory parameters (i.e. lipid profiles, serum creatinine, creatinin clearance) as well as vitamins and micronutrients (vitamin B6, B12, folate acid and iron status) are assessed. Additional parameters include the amount of medication (insulin dosage, metformin, antihypertensive therapy, etc.), the assessment of nephropathy (urine albumin excretion 24-hours urine sample), retinopathy (according to the EURODIAB six-level grading scale), peripheral neuropathy (assessed by biothesiometry of the big toe in both feet and questionnaire) and quality of life. Data assessment will be after randomization and then 3,6,12 months afterwards and then annually. | — |
Countries
Germany
Contacts
Public ContactBeat P. Müller
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg
Outcome results
None listed