‘Effect of fecal transplant harvested from bariatric surgery subjects on lipid and glucose metabolism in subjects with metabolic syndrome;the FEBALIGO trial
Completed
- Conditions
- insulin resistanceintestinal microbiotafecal transplantation
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
Male obese treatment naieve subjects with metabolic syndrome (n=22, 21 to 65 years-old; with metabolic syndrome
Able to give informed consent.
Exclusion Criteria
history of cardiovascular event (MI or pacemaker implantation)
cholecystectomy,
use of medication including PPI and antibiotics past three months,
(expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in insulin sensitivity (hyperinsulinemic euglycemic clamp with ([6,6-2H2]labeled glucose) [1,1,2,3,3-2H5]labeled glycerol) and fecal energy excretion (caloric bomb) between baseline and 2 weeks after treatment.
- Secondary Outcome Measures
Name Time Method Changes in adipose tissue inflammation in subcutaneous adipose tissue (biopsy) for insulin signalling cascade in relation to metabolic genes and macrophage counts; Intestinal transit time; fecal bileacids and shortchain fatty acids; Gut microbiota composition in small duodenal biopsies and feces <br>