metabool syndroom
Conditions
Interventions
Subjects will be given duodenal infusion of 10 ml E. Hallii 10E9/ml suspension
in glycerol or placebo (10 ml of glycerol alone).
E Hallii
Glucose metabolism metabolic syndrome
gut microbiome
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion 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 = 130/85 mmHg
Exclusion criteria
Exclusion criteria: A history of cardiovascular event (myocardial infarction or pacemaker implantation), smoking, cholecystectomy, use of any 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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is efficacy (changes in duodenal E. Hallii levels and gene expression (including FXR) 6 hours following single duodenal infusion of 10 ml E. Hallii. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are (short/longterm) effects of E hallii on glucose metabolism/insulin sensitivity using either 2 uur MMT ( Nutridrink) or 7 days continuous glucose measurement (Free Style libre glucose sensor) in relation to changes of E. Hallii and other microbiota in fecal samples collected at baseline, during week 1 and week 4. Dietary intake will be monitored during the course of the study. | — |
Countries
The Netherlands
Outcome results
None listed