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

X

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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