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C-Reactive Protein (CRP) in Obese Diabetic Women

This study has been completed.
Sponsor:
Collaborator:
Mexican National Institute of Public Health
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00262548
First received: October 26, 2005
Last updated: August 24, 2007
Last verified: August 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women

Resource links provided by NLM:

U.S. FDA Resources

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
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

No publications provided

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

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013