C-Reactive Protein (CRP) in Obese Diabetic Women
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00262548
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
- Menopausal
- Diagnosed diabetes mellitus type 2
- Obese (body mass index [BMI] > 25 ≤ 30)
Exclusion Criteria
- Fasting blood glucose ≥ 200 mg/dl
- CRP < 2 mg/L and > 10 mg/L
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patients will be receiving rosuvastatin/placebo for 6 months They will have baseline laboratory parameters taken such as glycemia HbA1c (glycosylated hemoglobin), low-density lipoprotein cholesterol (LDL-C), computed tomography (CT), high-density lipoprotein cholesterol (HDL-C), C-reactive protein (CRP), and retaken every 3 months Every month, patients will be evaluated at the clinic All participants will receive an intervention on diet and physical activity counseling, which will be carefully monitored.
- Secondary Outcome Measures
Name Time Method Other variables will be: proinflammatory cytokines - tumor necrosis factor (TNF)-alpha, interleukin-6 (IL-6), IL-12, Th2/Th3 cytokines -IL-4, IL-10 and transforming growth factor beta (TGF-beta)
Trial Locations
- Locations (1)
Research site
🇲🇽Cuernavaca, Morelos, Mexico