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Clinical Trials/NCT01947790
NCT01947790
Completed
Phase 4

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

Xiang Guang-da1 site in 1 country120 target enrollmentSeptember 2013

Overview

Phase
Phase 4
Intervention
pioglitazone group
Conditions
LVM
Sponsor
Xiang Guang-da
Enrollment
120
Locations
1
Primary Endpoint
The changes of LVM
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xiang Guang-da
Responsible Party
Sponsor Investigator
Principal Investigator

Xiang Guang-da

Pioglitazone regress the left ventricular mass in normotensive type 2 diabetic patients with ischeamia heart disease

Wuhan General Hospital of Guangzhou Military Command

Eligibility Criteria

Inclusion Criteria

  • type 2 diabetes
  • aged 40~75 years old

Exclusion Criteria

  • heart failure
  • renal failure
  • hypertension (\>130/80 mmHg)
  • hemoglobin A1c 9%

Arms & Interventions

Pioglitazone group

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

Intervention: pioglitazone group

Metformin group

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

Intervention: Metformin group

Outcomes

Primary Outcomes

The changes of LVM

Time Frame: The LVM will be measured at baseline, 6 momth and 9 month

Secondary Outcomes

  • The changes of endothelial function(The endothelial function will be measured at baseline, 6 month and 9 month)

Study Sites (1)

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