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OpenTrials
Completed

NCT Number: NCT00262548

C-Reactive Protein (CRP) in Obese Diabetic 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Research site

Cuernavaca, Morelos, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin; improvement of lipid profile

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Mexican National Institute of Public Health

Registry information

Official study title

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

Important dates

Study start
2005
First posted
Dec 7, 2005
Registry last updated
Aug 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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