Effect antibiotics on gutmicrobiota composition & insulin resistance.
- Conditions
- insulin resistance, obesity
- Registration Number
- NL-OMON24894
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Male obese subjects with metabolic syndrome (BMI > 30kg/m2, FPG>5.6 mmol/l);
2. Age 20-65 yr;
Exclusion Criteria
1. Patients with renal failure (kreatinine>135mmol/l);
2. Liver function problems (ASAT/ALAT>2x upper limit);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is changes in faecal flora composition after 7 days as well as 2, 4 and 6 weeks after the antibiotics.
- Secondary Outcome Measures
Name Time Method 1. Changes in insulin resistance (assessed by hyperinsulinemic normoglycemic clamp at baseline and after 7 days);<br /><br>2. Bile acid and lipidmetabolism (assessed by MMT at baseline and after 7 days);<br /><br>3. Changes in systemic inflammatory markers and lipid profiles at baseline as well as 7 days, 2, 4 and 6 weeks after antibiotics.