Table 1 Key exclusion criteria

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 recommendations^a

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 limit^a

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