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ID
Source
Brief title
Health condition
metabolic syndrome
insulin resistance
gut microbiota
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is effect on duodenal E. hallii levels as well as small intestinal gene expression (small intestinal biopsy) 6 hours after duodenal infusion of either E. hallii 10e9 cells in 10 ml glycerol 10% (active compound) OR 10ml of 10% glycerol alone (placebo).
Secondary outcome
Secondary endpoints are effect upon intervention
-(postprandial) glucose and metabolite during standardized mixed meal test
-changes in (postprandial) glucose excursions using continue glucose meter (Freestyle libre) in the days after intervention
-changes in E. hallii and other microbiota in fecal samples collected at baseline, 24h and week 1 and week 4 after intervention.
- effect on dietary intake (by online dietary lists).
Background summary
In this study we aim to study effect of single dose treatment with butyrate producing bacterial strain Eubacterium hallii versus placebo on small intestinal gene expression , intestinal e hallii levels, effect on (postprandial ) glucose and plasma metabolites excursions as well as changes in intestinal microbiota composition and effect on dietary intake.
Study objective
In this randomised, double-blind, placebo-controlled single centre study we propose to study the effect of duodenal infusion of single E. hallii treatment (administered via duodenal tube) on small intestinal gene expression, bacterial composition and (postprandial) glucose excursions in male subjects with metabolic syndrome
Study design
see above
Intervention
Subjects will be given duodenal infusion of 10 ml E. hallii suspension with a total concentration of 10e9 cells in 10% glycerol or 10ml 10 % glycerol only
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Inclusion criteria
In order to be eligible to participate in this study, patients must meet all of the following criteria:
- Caucasian males
- 21 to 69 years-old
- body mass index (BMI) 25 to 43 kg/m2
- At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose ≥ 5.6 mmol/l and/or HOMA-IR ≥ 2.5, triglycerides ≥ 1.6 mmol/l, waist-circumference > 102 cm HDL-cholesterol ≤ 1.04 mmol/l, blood pressure ≥ 130/85 mmHg
Exclusion criteria
A history of cardiovascular event (myocardial infarction or pacemaker implantation), smoking, cholecystectomy, use of medication including proton pump inhibitors (PPI as this influences intestinal microbiota composition see ref 3), oral anticoagulants and/or oral antibiotics in the past three months, (expected) prolonged compromised immunity (e.g. due to recent cytotoxic chemotherapy or HIV-infection with a CD4 count < 240). Subjects are also excluded if they have experienced excessive weightloss of >10% in the last months or have overt untreated GI disease/abnormal bowelhabits; moreover, if their levels of plasma aspartate aminotransferase and alanine aminotransferase are 2.5 times or more the upper limit of the normal range; if they have a history of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits); or overt Dm2.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6630 |
| NTR-old | NTR6807 |
| Other | : MEC 2017/158 |