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

Phase 4

Completed

• Conditions: LVM; Type 2 Diabetic Patients With IHD; Endothelial Function
• Interventions: Drug: pioglitazone group; Drug: Metformin group

• Registration Number: NCT01947790
• Lead Sponsor: Xiang Guang-da

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone group	pioglitazone group	Pioglitazone 15 mg/day will be given in this group for 9 months
Metformin group	Metformin group	Metformin 0.85 twice daily will be given in this group for 9 months as control.

Primary Outcome Measures

Name	Time	Method
The changes of LVM	The LVM will be measured at baseline, 6 momth and 9 month

Secondary Outcome Measures

Name	Time	Method
The changes of endothelial function	The endothelial function will be measured at baseline, 6 month and 9 month

Trial Locations

Locations (1)

Xiang Guangda; 🇨🇳 Wuhan, Hubei, China