Trials / Recruiting
RecruitingNCT05838287
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Academic / Other
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.
Detailed description
Either Pioglitazone or Placebo Pioglitazone will be administered during this study in this Type 2 Diabetic population with Heart Failure to examine if there are any beneficial effects on diastolic and systolic function. Myocardial blood flow (MBF) is measured using a PET scan, then participants will be randomized to pioglitazone or a placebo to examine the effects of the study drug on the effects on the systolic and diastolic function of the heart. In addition, myocardial insulin sensitivity change will be measured as well as myocardial fat content. The ratio of ATP: PCr will also be measured.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pioglitazone | Participants will be taking Pioglitazone tablets 1/day for 24 weeks. |
| DRUG | Placebo | Placebo for Pioglitazone |
Timeline
- Start date
- 2023-07-10
- Primary completion
- 2029-08-01
- Completion
- 2030-01-01
- First posted
- 2023-05-01
- Last updated
- 2025-08-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05838287. Inclusion in this directory is not an endorsement.