Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 2, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 19, 2015
August 1, 2015
1.8 years
September 2, 2013
August 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes of LVM
The LVM will be measured at baseline, 6 momth and 9 month
Secondary Outcomes (1)
The changes of endothelial function
The endothelial function will be measured at baseline, 6 month and 9 month
Study Arms (2)
Pioglitazone group
EXPERIMENTALPioglitazone 15 mg/day will be given in this group for 9 months
Metformin group
ACTIVE COMPARATORMetformin 0.85 twice daily will be given in this group for 9 months as control.
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- aged 40～75 years old
- with IHD
You may not qualify if:
- heart failure
- renal failure
- hypertension (\>130/80 mmHg)
- hemoglobin A1c 9%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiang Guang-dalead
Study Sites (2)
Unknown Facility
Wuhan, Hubei, 43000, China
Xiang Guangda
Wuhan, Hubei, 430070, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Pioglitazone regress the left ventricular mass in normotensive type 2 diabetic patients with ischeamia heart disease
Study Record Dates
First Submitted
September 2, 2013
First Posted
September 20, 2013
Study Start
September 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 19, 2015
Record last verified: 2015-08