Metabolic syndrome obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: Male obese (BMI > 30) subjects 21 to 65 years-old With at least 3 out of 5 metabolic syndrome criteria (fasting plasma glucose * 5.6 mmol/l, triglycerides * 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol
Exclusion criteria
Exclusion criteria: Patients: - Use of any medication, including proton pomp inhibitors and antibiotics in the past three months - Cholecystectomy - A history of cardiovascular event (MI or pacemaker implantation) - (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are changes in fecal, intestinal (biopsies) and oral microbiota composition and (the relation to) peripheral /hepatic insulin sensitivity (stable isotope based hyperinsulinemic euglycemic clamp and resting energy expenditure) at baseline and 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are changes in postprandial plasma lipids (mixed meal test) and subcutaneous adipose tissue inflammation (biopt) at baseline and 6 weeks. Finally, we will study effect on plasma and 24 feces and 24 urine metabolites at baseline, after 3 and 6 weeks | — |
Countries
The Netherlands