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

Xiang Guang-da

Status and phase: Completed; Phase 4

Conditions: Endothelial Function; Type 2 Diabetic Patients With IHD; LVM

Treatments: Drug: pioglitazone group; Drug: Metformin group

Study type: Interventional

Funder types: Other

Identifiers

NCT01947790

2013Wze051

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Pioglitazone group

Experimental group

Description:

Pioglitazone 15 mg/day will be given in this group for 9 months

Treatment:

Drug: pioglitazone group

Metformin group

Active Comparator group

Description:

Metformin 0.85 twice daily will be given in this group for 9 months as control.

Treatment:

Drug: Metformin group