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

Primary Purpose

LVM, Type 2 Diabetic Patients With IHD, Endothelial Function

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

pioglitazone group

Metformin group

About this trial

This is an interventional treatment trial for LVM focused on measuring Type 2 diabetes, left ventricular mass, pioglitazone

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

Xiang Guangda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pioglitazone group

Metformin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The changes of LVM

Secondary Outcome Measures

The changes of endothelial function

Full Information

NCT ID

NCT01947790

First Posted

September 2, 2013

Last Updated

August 17, 2015

Sponsor

Xiang Guang-da

1. Study Identification

Unique Protocol Identification Number

NCT01947790

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiang Guang-da

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

LVM, Type 2 Diabetic Patients With IHD, Endothelial Function

Keywords

Type 2 diabetes, left ventricular mass, pioglitazone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pioglitazone group

Arm Type

Experimental

Arm Description

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

Arm Title

Metformin group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

pioglitazone group

Intervention Type

Drug

Intervention Name(s)

Metformin group

Primary Outcome Measure Information:

Title

The changes of LVM

Time Frame

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

Secondary Outcome Measure Information:

Title

The changes of endothelial function

Time Frame

The endothelial function will be measured at baseline, 6 month and 9 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%

Facility Information:

City

Wuhan City

State/Province

Hubei

ZIP/Postal Code

43000

Country

China

Facility Name

Xiang Guangda

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430070

Country

China

12. IPD Sharing Statement

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

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