metabolic syndrome insulin resistance gut microbiota
Conditions
Interventions
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
Sponsors
AMC-UVA
Eligibility
Inclusion criteria
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
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 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 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
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactErik Stroes
Department of Vascular Medicine, AMC
Outcome results
None listed