Actively Recruiting
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-08-27
78
Participants Needed
1
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and available for the study duration
- Male or female aged 30 to 70 years
- Body Mass Index (BMI) between 27.5 and 40 kg/m²
- HbA1c between 6.5% and 10%
- Blood pressure less than or equal to 145/65 mmHg
- eGFR greater than 45 ml/min/1.73m²
- Heart failure with preserved ejection fraction (EF > 50% by ECHO screening)
- New York Heart Association (NYHA) class II-III heart failure
- Type 2 diabetes treated with diet/exercise, metformin, sulfonylurea, metformin/sulfonylurea, DPP4 inhibitors, or insulin
- Females of reproductive potential must use highly effective contraception for at least 1 month before screening and during study participation plus 4 weeks after
- Males of reproductive potential must use condoms or other effective contraception with partner
You will not qualify if you...
- History of osteoporosis or proliferative diabetic retinopathy
- Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or severe valvular heart disease
- Symptomatic coronary artery disease
- Significant change in diuretic medication in the month before screening
- Treatment with GLP-1 receptor agonists or thiazolidinediones
- Treatment with SGLT2 inhibitors
- Pregnancy or lactation
- Known allergies to study intervention components
- Presence of metal plates, screws, shrapnel, pins in the body, or a cardiac pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Diabetes Institute/UH
San Antonio, Texas, United States, 78229-3900
Actively Recruiting
Research Team
S
Sivaram Neppala, MD
CONTACT
A
Andrea Hansis-Diarte, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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