Key inclusion criteria | Key exclusion criteria | Exclusion criteria for specific examinations |
---|---|---|
Diagnosis of type 1 DM and type 2 DM including maturity onset diabetes of the young (MODY) and latent autoimmune diabetes of the adult (LADA) based on current ADA recommendationsa Onset of DM within the last 12 months Diagnosis of type 1 DM based on diabetes manifestation with ketoacidosis or immediate insulin requirement along with the presence of at least one islet cell directed autoantibody or C-peptide levels below detection limita Age of 18–69 years | Secondary DM according to ADA criteria (Type 3 B-H, e.g. pancreoprive DM) Type 4 (gestational) DM, pregnancy Poor glycemic control (HbA1c > 9.0 %) Hyperlipidemia (triglycerides and low-density lipoproteins ≥double upper reference limit) Heart, renal, liver failure (NYHA ≥II, serum creatinine ≥1.6 mg/dl, Aspartate-Aminotransferase/Alanine-Aminotransferase/Gamma-Glutamyltransferase Peripheral artery occlusive disease IV Venous thromboembolic events Anemia, blood donation or participation in a clinical study within the past 3 months Acute infection, leukocytosis, immunosuppressive therapy, autoimmune diseases, infection with human immunodeficiency virus, other severe diseases (e.g. active cancer disease) Psychiatric disorders, limited cooperation ability | Neurologic examination: corneal disorders, and neuropathy from causes other than diabetes Spiroergometry: electrocardiogram abnormalities (alterations of the ST segment, higher-grade arrhythmia), unstable angina pectoris, uncontrolled hypertonia Magnetic resonance spectroscopy/imaging: metallic implants (cardiac pacemaker or defibrillator, cochlear implants, implanted catheters, clips, prosthetic valves), metallic fragments (metal removed from eye, ever worked as metal worker), larger tattoos, waist circumference > 135 cm, claustrophobia Tissue biopsies: effective anticoagulation therapy, platelet aggregation inhibitors >100 mg acetylsalicylate |