Effect of Fecal transplant harvested from Bariatric surgery subjects on Lipid and Glucose metabolism in subjects with metabolic syndrome;

Effect of Fecal transplant harvested from Bariatric surgery subjects on Lipid and Glucose metabolism in subjects with metabolic syndrome; - FEBALIGO study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38792

Enrollment

Registered

2013-07-31

Start date

2013-11-22

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Metabolic syndrome obesity and type 2 diabetes

Interventions

Patients will be randomised to one of the two treatment arms: single allogeneic feces (post bariatric surgery donor feces in the bowel by duodenal tube) vs. single allogeneic feces from a pre-bariat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: Males Meeting the criteria for metabolic syndrome (ATP-III criteria) No relevant (confounding) comorbidity or medication use;Feces donors post-RYGB: Males +- 1 year after gastric bypass with significant weight loss No relevant (confounding) comorbidity free of transmissible diseases upon screening;Feces donors pre-RYGB: Males Scheduled for gastric bypass (RYGB) No relevant (confounding) comorbidity free of transmissible diseases upon screening

Exclusion criteria

Exclusion criteria: Patients: relevant comorbidity additional medication use except when directly related to metabolic syndrome antibiotic use in the last 3 months;Feces donors (pre- and post-RYGB): relevant morbidity medication use PPI or antibiotic use in the last 3 months frequent patient contact

Design outcomes

Primary

Measure	Time frame
Changes in insulin sensitivity and de novo lipogenesis as measured by hyperinsulinemic euglycemic clamp with stable isotopes at 0 and 2 weeks and by measuring energy excretion, short chain fatty acids profile and bile acid concentration in 2x 24h collected feces.	—

Secondary

Measure	Time frame
Secondary and further study parameters needed to answer the research question: Changes in adipose tissue inflammation by subcutaneous adipose tissue biopsy (to assess phosphorylation status of the insulin signalling cascade in relation to metabolic genes (perilipin3) and to evaluate dipose tissue inflammation (macrophage counts). Inflammatory markers in serum will also be measured. Tertiary end points: small and large intestinal microbiota in relation to intestinal transit time (segmental SITZMARKS) at 0 and 2 weeks.	—

Measure

Time frame

Secondary and further study parameters needed to answer the research question: Changes in adipose tissue inflammation by subcutaneous adipose tissue biopsy (to assess phosphorylation status of the insulin signalling cascade in relation to metabolic genes (perilipin3) and to evaluate dipose tissue inflammation (macrophage counts). Inflammatory markers in serum will also be measured. Tertiary end points: small and large intestinal microbiota in relation to intestinal transit time (segmental SITZMARKS) at 0 and 2 weeks.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)