Diabetes Mellitus, Type 2
Conditions
Keywords
Obesity, Menopause
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.
Interventions
DRUGRosuvastatin; improvement of lipid profile
Sponsors
Mexican National Institute of Public Health
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| They will have baseline laboratory parameters taken such as glycemia | — |
| Patients will be receiving rosuvastatin/placebo for 6 months | — |
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Mexico
Outcome results
None listed