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

NCT ID: NCT01947790

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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LVM Type 2 Diabetic Patients With IHD Endothelial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pioglitazone group

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

Group Type EXPERIMENTAL

pioglitazone group

Intervention Type DRUG

Metformin group

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

Group Type ACTIVE_COMPARATOR

Metformin group

Intervention Type DRUG

Interventions

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pioglitazone group

Intervention Type DRUG

Metformin group

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiang Guang-da

OTHER

Sponsor Role lead

Responsible Party

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Xiang Guang-da

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Wuhan, Hubei, China

Site Status

Xiang Guangda

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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2013Wze051

Identifier Type: -

Identifier Source: org_study_id

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