Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease

Endothelial Function Clinical Trial

Official title:

Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947790
• Other study ID #: 2013Wze051
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2013
• Last updated: August 17, 2015
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Wuhan General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel coronary disease or impaired left ventricular function. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will be reduced if we can find novel therapies to regress LVH.

Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study, we will treat patients with pioglitazone, and we will also metformin as control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes

• aged 40~75 years old

• with IHD

Exclusion Criteria:

• heart failure

• renal failure

• hypertension (>130/80 mmHg)

• hemoglobin A1c 9%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Endothelial Function
• Heart Diseases
• LVM
• Type 2 Diabetic Patients With IHD

Intervention

Drug:
• pioglitazone group

• Metformin group

Locations

Country	Name	City	State
China	Xiang Guangda	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiang Guang-da

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of LVM		The LVM will be measured at baseline, 6 momth and 9 month	Yes
Secondary	The changes of endothelial function		The endothelial function will be measured at baseline, 6 month and 9 month	Yes