An investigation into the modulation of obesity associated monocyte/macrophage function, vascular inflammation and insulin resistance by PPAR agonist treatment
Phase 1
- Conditions
- The proposed study will investigate early indicators of cardiovascular disease and diabetes in healthy, obese men without a family history of diabetes and whether these are changed by treatment with the common PPAR agonists fenofibrate andpioglitazone.
- Registration Number
- EUCTR2006-004296-35-GB
- Lead Sponsor
- The Royal Group of Hospitals, Belfast Health and Social Care Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
Controls: male, 35-65 years, BMI 20-25 Kg/M2
Cases: male, 35-65 years, BMI > 30 Kg/M2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
cigarette smoking, clinical cardiac disease, plasma cholesterol > 7 mmol/l, fasting
triglycerides > 5mmol/l, blood pressure > 160/90 mmHg, diabetes/family history of diabetes, glucose intolerance or use of hypertensive; cardiac; vitamin; non-steroidal anti-inflammatory drugs or lipid-lowering therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The proposed study will investigate early indicators of cardiovascular disease and diabetes in healthy, obese men without a family history of diabetes and whether these are changed by treatment with the PPAR agonists supralip 160 and<br>pioglitazone.;Secondary Objective: To determine whether non-diabetic obese men display early indicators of cardiovascular disease and/or diabetes namely increased circulating levels of inflammatory chemicals, altered blood vessel function and changes in fat tissue composition.<br>To determine whether supralip 160 and pioglitazone have effects on the early indicators of cardiovascular disease and/or diabetes listed above.;Primary end point(s): Peripheral / adipose monocyte inflammatory activation and insulin sensitivity
- Secondary Outcome Measures
Name Time Method