NCT05838287 · The University of Texas Health Science Center at San Antonio
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
(PIOHF)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Pioglitazone
Participants will be taking Pioglitazone tablets 1/day for 24 weeks.
DRUG
Placebo
Placebo for Pioglitazone
Primary outcome measures
Change in Systolic function
Time frame: Baseline and 6-months post treatment (approximately 24 weeks)
Measurement of change in systolic function of the heart using cardiac MRI
Change in Diastolic function
Time frame: Baseline and 6-months post treatment (approximately 24 weeks)
Measurement of change in diastolic function of the heart using cardiac MRI
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 30-70 years
- Body Mass Index (BMI) of 27.5-40kg/m²
- HbA1c of 6.5 to 10%
- Blood pressure of less than or equal to 145/65mmHg
- eGFR greater than 45 ml/min/1.73m²
- Subject must have HFpEF (EF \> 50% by ECHO screening)
- NYHA class II-III heart failure
- Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional \[4 weeks\] after the end of study participation.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion criteria
- Subjects with history of osteoporosis or proliferative diabetic retinopathy
- Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
- Patients with symptomatic coronary artery disease.
- Subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication).
- Subjects treated with a GLP-1 RA or thiazolidinedione.
- Subjects treated with a SGLT2i
- Pregnancy or lactation
- Known allergic reactions to components of the study interventions.
- Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
Where
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2025 · Source of record for eligibility and locations