C-Reactive Protein (CRP) in Obese Diabetic Women

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00262548

Collaborator

Mexican National Institute of Public Health (Other)

100

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Rosuvastatin; improvement of lipid profile	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women

Study Start Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

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

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research site	Cuernavaca	Morelos	Mexico

Sponsors and Collaborators

AstraZeneca
Mexican National Institute of Public Health

Investigators

Study Director: Astra Zeneca Mexico Medical Director, MD, AstraZeneca
Principal Investigator: Simón Barquera Cervera, MD, Mexican National Institute of Public Health