C-Reactive Protein (CRP) in Obese Diabetic Women - Full Text View

Sponsors and Collaborators:	AstraZeneca Mexican National Institute of Public Health
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00262548

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Rosuvastatin; improvement of lipid profile	Phase IV

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Rosuvastatin Rosuvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women

Further study details as provided by AstraZeneca:

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)

Estimated Enrollment:	100
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262548

Locations

Mexico, Morelos
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

More Information

Study ID Numbers:	DM-CRESTOR-0001, D3560L00018
Study First Received:	October 26, 2005
Last Updated:	August 24, 2007
ClinicalTrials.gov Identifier:	NCT00262548
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by AstraZeneca:

Obesity
Menopause

Study placed in the following topic categories:

Obesity
Rosuvastatin
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Menopause

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009