C-Reactive Protein (CRP) in Obese Diabetic Women

August 24, 2007 updated by: AstraZeneca

Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2007

Last Update Submitted That Met QC Criteria

August 24, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM-CRESTOR-0001
  • D3560L00018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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