insulin resistance, overweight, gutmicrobiota
Conditions
Interventions
allogenic healthy (postbariatric surgery) donor feces transplantation + placebo tablets for 4 weeks VERSUS autologous fecal transplantation + sodium butyrate tablets for 4 weeks
Sponsors
AMC-uvA
Eligibility
Inclusion criteria
Inclusion criteria: - Caucasian male or postmenopausal female - 50-70 years old - BMI ≥30 kg/m2 - At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose ≥ 5.6 mmol/l, triglycerides ≥ 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol 1.04 mmol/l, blood pressure ≥ 130/85 mmHg - Subjects should be able and willing to give informed consent
Exclusion criteria
Exclusion criteria: -Any Medication use, including PPI and antibiotics in last 3 months - Drug abuse - Alcohol abuse (>3/day) - Participation in a research protocol involving radiation exposure in the last 2 years. - eGFR <60 ml/min - Contraindication for MRI (claustrophobia) - History of cardiovascular event (MI or pacemaker implantation) - Cholecystectomy - Expected prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Insulin sensitivity and lipolysis (2-step hyperinsulinemic euglycemic clamp) - Hypothalamic (SPECT-scan), small intestinal (biopsy) and urinal (24h urine sample) serotonin levels in relation to satiety testing | — |
Secondary
| Measure | Time frame |
|---|---|
| - Faecal energy excretion and short chain fatty acid and bile acid concentration in feces - Dietary intake (dietary lists), resting energy expenditure (calorimetry) and physical activity energy expenditure (accelerometers) - Faecal and small intestinal gut microbiota composition (morning stool samples and biopsies) - Intestinal permeability (faecal calprotectin levels) - Intestinal passage time (Sitzmark capsules) - Sympathetic tone (Nexfin) - Inflammatory and lipid-proteomic markers (blood samples) - Liver fat for NAFLD/NASH degree (MRI) | — |
Contacts
Public ContactM. Nieuwdorp
AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2
Outcome results
None listed