insulin resistance, obesity, gut microbiota, SCFA
Conditions
Interventions
Patients will be randomised to one of the three treatment arms:
Single (baseline) or multiple (at baseline and after 6 weeks) allogenic feces (infusion of lean donor feces by duodenal tube) or single
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male obese subjects with metabolic syndrome (n=45); 2. 21 to 69 years-old; 3. Body mass index (BMI) 30 to 43 kg/m2); 4. At least 3 out of 5 NCEP metabolic syndrome criteria.
Exclusion criteria
Exclusion criteria: 1. Cardiovascular event (MI or pacemaker implantation); 2. Use of medication including PPI and antibiotics; 3. (Expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is changes in weight in relation to fecal flora composition and short chain fatty acid metabolism in fecal samples after 3, 6, 12 and 18 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are changes in insulin resistance/fatty acid metabolism (assessed by hyperinsulinemic euglycemic clamp and stable isotope glucose infusion) and postprandial lipid metabolism (mixed meal test) at baseline and after 6 and 18 weeks. Before each mixed meal test a subcutaneous adipose tissue biopsy will be obtained to assess phosphorylation status of the insulin signalling cascade in relation to metabolic genes (perilipin3). Finally, during positioning of duodenal tube, biopsies will be taken at baseline and after 6 & 18 weeks to study small intestine epithelium composition. | — |
Contacts
Public ContactA. Vrieze
PO Box 22660
Outcome results
None listed