E11 K76.0
Conditions
Interventions
Group 1: 14-day medically supervised water-only fasting + supervised muscle strength training: Water-only fasting includes the intake of water and unsweetened cold and hot drinks. Sufficient salt inta
Sponsors
Charité - Universitätsmedizin Berlin, Charité-Hochschulambulanz für Naturheilkunde im Immanuel-Krankenhaus Berlin-Wannsee
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Presence of type 2 diabetes mellitus (= last 3 months no change in therapy) - HbA1c = 6.5% without medication or 6.0% with medication - Sonographically suspected fatty liver disease or existing MRI evidence of fatty liver disease - Written informed consent form available
Exclusion criteria
Exclusion criteria: - Intensified insulin therapy - No sufficient verbal communication possible - Dementia or other severely cognitively impairing disease - Current pregnancy or breastfeeding - Other serious medical, neurological or psychiatric conditions - History of gout - History of gallstones / diagnosis of cholecystolithiasis - Participation in another study - Potential difficulties with the MRI scan, e.g. claustrophobia, pacemaker, electronic or magnetically responsive implants, permanent make-up, tattoos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-resolution MRI for assessing interstitial fat in the liver and pancreas before and after fasting | — |
Secondary
| Measure | Time frame |
|---|---|
| - bioelectrical impedance analysis (BIA): Bioelectrical impedance analysis (BIA) estimating body composition, in particular body fat and muscle mass [Time Frame: Baseline, 4-8 days after fasting, 4-8 days after end of muscle training] - Metabolic laboratory parameters: HOMA-IR, HbA1c, fasting glucose, Insuline, C-peptide, blood panel, CRP, gGT, GOT, GPT, Creatinine, urea, Crea-Clearance, electrolytes, Cholesterol (incl. HDL, LDL), Triglycerides [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Fatty liver index: The fatty liver index is an algorithm including body mass index (BMI), waist circumference (WC), gamma-glutamyl transferase (GGT), and triglyceride (TG) levels [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Cardiovascular outcomes: Blood pressure and heart rate [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Anthropometry: Waist, abdominal and hip circumference, weight, body mass index [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Patient-reported outcomes (PROs): Questionnaires on well-being (WHO-5), health (SF-12), on diabetes (PAID, BDI), VAS on complaints, questions on eating behavior and fasting experience [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Functional laboratory analyses: Thrombocyte and coagulation functions [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Muscle strength: Hand grip strength, 1 repetition maximum, 30 and 60 sec sit to stand test [Time Frame: Baseline, 4-8 days after last day of fasting, 4-8 days after end of muscle training] - Laboratory measurements for muscle build-up: Estrogen- and testosterone levels, FGF-21, IGF-1, Vitamine B12, folic acid, Vitamine D, Ferritin [Time Frame: Baseline, 4-8 days after la | — |
Countries
Germany
Contacts
Public ContactDaniela Koppold
Charité - Universitätsmedizin Berlin, Charité-Hochschulambulanz für Naturheilkunde im Immanuel-Krankenhaus Berlin-Wannsee
Outcome results
None listed