‘Effect of fecal transplant harvested from bariatric surgery subjects on lipid and glucose metabolism in subjects with metabolic syndrome;the FEBALIGO trial

‘Effect of fecal transplant harvested from bariatric surgery subjects on lipid and glucose metabolism in subjects with metabolic syndrome; the FEBALIGO trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22091

Enrollment

Registered

2013-12-19

Start date

2013-12-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insulin resistance intestinal microbiota fecal transplantation

Interventions

fecal transplantation using either feces from subjects after bariatric surgery or subjects before bariatric surgery in metablic syndrome

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)