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C-Reactive Protein (CRP) in Obese Diabetic Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262548
First Posted: December 7, 2005
Last Update Posted: August 28, 2007
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.
Collaborator:
Mexican National Institute of Public Health
Information provided by:
AstraZeneca
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00262548


Locations
Mexico
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

ClinicalTrials.gov Identifier: NCT00262548     History of Changes
Other Study ID Numbers: DM-CRESTOR-0001
D3560L00018
First Submitted: October 26, 2005
First Posted: December 7, 2005
Last Update Posted: August 28, 2007
Last Verified: August 2007

Keywords provided by AstraZeneca:
Obesity
Menopause

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors