DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m²

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00004550
• Lead Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.