C-Reactive Protein (CRP) in Obese Diabetic Women

AstraZeneca100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosuvastatin; improvement of lipid profileDRUG

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Research site

Cuernavaca, Morelos, Mexico

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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