E11.90 E88.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A signed consent form 2. Age 25 - 70 years 3. Existence of a specialist secure type 2 diabetes mellitus (HbA1c> 7%) 4. Maximum basal insulin 40 IU 5. BMI > 25Kg/cm ² 6. Waist cm men > 94, women > 80 cm 7. Patient is intellectually and linguistically able to understand the significance of the study
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation period 2. Diabetes mellitus type-1 with basal-bolus insulin therapy 3. Lack of insulin C-peptide> 1.2 ng / dl 4. Hypotension 2b 10. Diabetic foot syndrome > Wagner 1, A Armstrong 11. Manifest eating disorder or binge-eating disorder 12. Serious acute somatic disease or infectious disease 13. Severe or acute mental illness 14. Simultaneous participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in long-term blood sugar (HbA1c) using a blood collection: baseline (day 0) versus endpoint (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| - HOMA score for insulin sensitivity - Quality of Life (WHO-5) - Overall assessment of efficacy and tolerability (Likert scale) by the patient - Weight, abdominal girth - HbA1 C, glucose and insulin levels - Blood pressure, systolic / diastolic - Blood lipids (Chol LDL-C, HDL-C, TG): baseline (day 0) versus endpoint (12 weeks). | — |
Countries
Germany
Contacts
diR Schwerpunktpraxis Diabetes & Rheuma Wilmersdorf