NCT Number: NCT01947790
Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
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.
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Notify MeKey information
Conditions
Age range
40 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Xiang Guangda, Wuhan, Hubei, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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%
Treatment and study plan
Metformin Group
DrugPrimary 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
Time frame: The endothelial function will be measured at baseline, 6 month and 9 month
Sponsors and collaborators
Lead sponsor
Xiang Guang-da
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 20, 2013
- Registry last updated
- Aug 19, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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