C-Reactive Protein (CRP) in Obese Diabetic Women

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262548
• Other study ID #: DM-CRESTOR-0001
• Secondary ID: D3560L00018
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2005
• Last updated: August 24, 2007
• Start date: October 2005

Study information

• Verified date: August 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosuvastatin; improvement of lipid profile

Locations

Country	Name	City	State
Mexico	Research site	Cuernavaca	Morelos

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Mexican National Institute of Public Health

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients will be receiving rosuvastatin/placebo for 6 months
Primary	They will have baseline laboratory parameters taken such as glycemia
Primary	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
Primary	Every month, patients will be evaluated at the clinic
Primary	All participants will receive an intervention on diet and physical activity counseling, which will be carefully monitored.
Secondary	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)