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C-Reactive Protein (CRP) in Obese Diabetic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262548
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : August 28, 2007
Mexican National Institute of Public Health
Information provided by:

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Patients will be receiving rosuvastatin/placebo for 6 months
  2. They will have baseline laboratory parameters taken such as glycemia
  3. 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
  4. Every month, patients will be evaluated at the clinic
  5. All participants will receive an intervention on diet and physical activity counseling, which will be carefully monitored.

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262548

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Research site
Cuernavaca, Morelos, Mexico
Sponsors and Collaborators
Mexican National Institute of Public Health
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Study Director: Astra Zeneca Mexico Medical Director, MD AstraZeneca
Principal Investigator: Simón Barquera Cervera, MD Mexican National Institute of Public Health

Layout table for additonal information Identifier: NCT00262548    
Other Study ID Numbers: DM-CRESTOR-0001
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: August 28, 2007
Last Verified: August 2007
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors