E66.82
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Obese patients with BMI > 40 kg/m² or BMI > 35 kg/m² and obesity related co-morbidities (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnoe syndrome); failed 6 months multimodal standardized conservative obesity therapy; indication for bariatric procedure; written informed consent
Exclusion criteria
Exclusion criteria: 1. Taking medications that lead to insulin resistance (cortisol, growth hormone, rheumatism) 2. Chemotherapy within 8 weeks before surgery 3. An advanced liver disease (cirrhosis) 4. Patients who have already received an organ transplant 5. Patients with severe infectious disease 6. Any factors that limit the ability of the patient to cooperate during study ( mental function or drug abuse)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of liver fat content after three weeks of dietary intervention using MRT scan (t0: before diet; t1: after three weeks of diet) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometrical measurements (weight, height, waist circumference); blood pressure and electrocardiogram; visceral fat mass using MRT scan; abdominal subcutaneous fat mass using MRT scan; total fat mass (BIA and BodPod measurements); fat-free mass (BIA and BodPod measurements); analysis of glucose metabolism using oral glucose tolerance test; routine biochemistry of liver and kidney parameters in blood and urine samples (gamma GT, ALAT, ASAT, LDL cholesterol, HDL cholesterol, triglycerides etc.); measurement of serum marker of liver fat (cytokeratin 18, fetuin A, FGF21), inflammation markers (IL18, IL6, TNFa, progranulin, chemerin), hormones of glucose metabolism (insulin, C-peptide, glucagon), adipokines (adiponectin, leptin) using ELISA; these measurements are performed before (t0) and after three weeks of dietary intervention (t1). Histological analysis of liver, visceral and subcutaneous adipose tissue; gene expression in the liver, visceral and subcutaneous adipose tissue using real-time PCR; protein expression in the liver, visceral and subcutaneous adipose tissue using western blot; mitochondrial activity in liver using OROBOROS; these measurements are performed after three weeks of dietary intervention (t1). | — |
Countries
Germany
Contacts
Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke, Abteilung Klinische Ernährung