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
  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:


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
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, see Learn About Clinical Studies.

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 October 01, 2014