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Table 1 Inclusion and exclusion criteria

From: 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: study protocol of a randomized controlled multicenter trial - DRKS00004550

Inclusion criteria Exclusion criteria
Diagnosis of T2DM with insulin therapy for at least 3 months and an HbA1c of ≥7%; negative islet cell autoantibody testing will be required for patients that received insulin therapy within 1 year after T2DM diagnosis Type I diabetes mellitus or latent autoimmune diabetes of adults (LADA)
Proof of at least one microvascular manifestation of diabetes (for example, nephropathy, retinopathy, neuropathy) T2DM on diet and/or oral medication
Residual pancreatic function, which is the premise for autogenic glycemic control assessed by stimulated fasting C-peptide laboratory tests with a minimum of 1.5 ng/mL Heart failure (NYHA III-IV)
BMI 26–35 kg/m2 Malignant disease in the past 5 years
Age 30 to 65 years History of major abdominal operation
Permanent glucocorticoid or other immunosuppressive therapy
Pituitary disease/Morbus Addison
Renal failure (glomerular filtration rate < 45 ml/min)
Proof of any liver cirrhosis above grade A according to the Child-Pugh-classification
  Expected lack of compliance or inability to informed consent