Effect of Fecal transplant harvested from Bariatric surgery subjects on Lipid and Glucose metabolism in subjects with metabolic syndrome;
- Conditions
- Metabolic syndrome obesity and type 2 diabetes100274241001842410013317
- Registration Number
- NL-OMON38792
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Changes in insulin sensitivity and de novo lipogenesis as measured by<br /><br>hyperinsulinemic euglycemic clamp with stable isotopes at 0 and 2 weeks and by<br /><br>measuring energy excretion, short chain fatty acids profile and bile acid<br /><br>concentration in 2x 24h collected feces.<br /><br><br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary and further study parameters needed to answer the research question:<br /><br>Changes in adipose tissue inflammation by subcutaneous adipose tissue biopsy<br /><br>(to assess phosphorylation status of the insulin signalling cascade in relation<br /><br>to metabolic genes (perilipin3) and to evaluate dipose tissue inflammation<br /><br>(macrophage counts). Inflammatory markers in serum will also be measured.<br /><br><br /><br>Tertiary end points:<br /><br>small and large intestinal microbiota in relation to intestinal transit time<br /><br>(segmental SITZMARKS) at 0 and 2 weeks.</p><br>