| Trial ID: | L2416 |
| Source ID: | NCT00262548
|
| Associated Drug: |
Rosuvastatin; Improvement Of Lipid Profile
|
| Title: |
C-Reactive Protein (CRP) in Obese Diabetic Women
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Rosuvastatin; improvement of lipid profile
|
| Outcome Measures: |
Primary: 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: 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)
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Mexican National Institute of Public Health
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-10
|
| Completion Date: |
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| Results First Posted: |
|
| Last Update Posted: |
2007-08-28
|
| Locations: |
Research site, Cuernavaca, Morelos, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT00262548
|
