RecruitingPhase 4NCT05838287

Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

78 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pioglitazone — a medication normally used for type 2 diabetes — can also help improve heart function in people with both type 2 diabetes and a specific type of heart failure called HFpEF, where the heart muscle contracts normally but the chambers are too stiff. **You may be eligible if...** - You are 30 to 70 years old - You have type 2 diabetes with HbA1c between 6.5% and 10% - You have been diagnosed with HFpEF (heart pumping fraction above 50%) - Your BMI is between 27.5 and 40, your blood pressure is reasonably controlled, and kidney function is adequate **You may NOT be eligible if...** - You have a different type of heart failure (with reduced ejection fraction) - You have severe kidney or liver disease - You are on insulin or certain other diabetes medications - You have a history of bladder cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPioglitazone

Participants will be taking Pioglitazone tablets 1/day for 24 weeks.

DRUGPlacebo

Placebo for Pioglitazone


Locations(1)

Texas Diabetes Institute/UH

San Antonio, Texas, United States

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NCT05838287


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