insuline resistance obesity
Conditions
Interventions
None listed
Sponsors
Vasculaire Geneeskunde
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - BMI>40 kg/m2 or >35 kg/m2 with obesity related co-morbidity - Reasonable supervised attempts to lose weight - 18-65 years of age 4.2 Inclusion criteria - Scheduled for bariatric surgery - Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Primary lipid disorder All medical and psychiatric conditions except for obesity related disease Coagulation disorders (prolonged PT, aPTT) Uncontrolled hypertension (RR>150/9 mmHg) Renal insufficiency (creatinin >150 umol/L) Excessive alcohol intake (>14 units/week) Pregnancy, females who are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. NAFLD/NASH parameters in liver biopsy 2. 2h Mixed meal tolerance test for level of insulin sensitivity; 3. Presence of bacterial DNA/bacterial metabolites in portal vein blood, liver and abdominal adipose tissue depots 4. Small intestinal and faecal microbiota composition 5. Expression and differentiation of intestinal immunological cells in GALT (Peyer*s patches), visceral/subcutaneous adipose tissue, liver and peripheral blood (notably ILC*s, macrophages, T/B-cells and dendritic cells) in relation to inflammation gene expression (IL -1β, IL-6, IL-8, IL-18, CXCR2 TNF-a and TLR 1, 2, 4, 5 and 6) in PBMCs 6. Dietary and satiety lists and excreted metabolites (24h faeces and urine) 7. Clinical data (body weight, waist circumference, blood pressure and assessment of cardiac output and baroreflex sensitivity (nexfin), in addition information will be collected regarding medication, comorbidity, complications of surgery, presence of mental problems, smoking, use of alcohol and a DNA sample will be taken) up till 10 years after surgery. 8. Ultrasonography for the detection of gallstones 9. Gallbladder tissue and bile acid collection after cholecystectomy surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting blood samples, dietary and satiety lists and excreted metabolites (24h faeces and urine as well as BIA and questionnaires) and ECG at 12 months; 2. 2h Mixed meal tolerance test for level of insulin sensitivity and dietary and satiety lists and excreted metabolites (24h faeces and urine as well as BIA and questionnaires) and ECG at 24 months; 3. Faecal microbiota composition and peripheral blood inflammatory markers at 2, and 6 weeks, 6 and 12 months, up until 10 years after surgery; also oral microbiota at baseline, 12 and 24 months up until 10 years. 4. Expression and differentiation of immunological cells (notably ILC*s, macrophages) and inflammatory markers (IL6, IRX3 and 5) at 12 and 24 months up until 10 years after surgery | — |
Countries
Netherlands
Outcome results
None listed