NCT01588470

Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the existence of heart abnormalities in patients with diabetes and the effect of pioglitazone in correcting these abnormalities.

Detailed description

PRIMARY OBJECTIVES 1. To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects. 2. To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects. 3. To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects. 4. 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.

Conditions

• Type 2 Diabetes
• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	pioglitazone	45 mg per day for 6 months

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2012-05-01
• Last updated: 2017-12-06
• Results posted: 2017-12-06