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Table 1 Key exclusion criteria

From: Cohort profile: the German Diabetes Study (GDS)

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
  1. a American Diabetes Association [60]