Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01588470|
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Coronary Heart Disease||Drug: pioglitazone||Phase 4|
- To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.
- To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects.
- To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects.
- To examine the effect of pioglitazone on myocardial insulin sensitivity, pericardial fat content, and cardiac function.
SECONDARY OBJECTIVES To examine the relationships between myocardial insulin sensitivity, pericardial fat content, and cardiac function.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
this study includes single arm intervention with pioglitazone. T2DM individuals will be studied at baseline and after 6 months treatment.
as a reference group, healthy subjects will be studied in cross sectional fashion. Because healthy subjects will not be treated nor restudied at 6 months, they can not be considered a separate arm in the study but rather a reference group
|Masking:||None (Open Label)|
|Official Title:||Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM) - Role of Intramyocellular Lipid Content and Mitochondrial Dysfunction in Myocardial Insulin Resistance and Their Correction With Pioglitazone|
|Study Start Date :||June 2006|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone
45 mg per day for 6 months
Other Name: Actos
- Change in E to A Ratio [ Time Frame: Baseline and 6-months Post Treatment ]The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.
- Myocardial Glucose Uptake [ Time Frame: Baseline and 6-months Post Treatment ]Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone
- Change in Hemoglobin A1c [ Time Frame: Baseline and 6-months Post Treatment ]Change in hemoglobin A1c levels measured at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588470
|Principal Investigator:||Ralph A DeFronzo, MD||University of Texas|