Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 30 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: PET scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests pioglitazone, a diabetes medicine, in adults with type 2 diabetes, obesity, and heart failure where the heart still pumps out a normal share of blood. It looks at how heart cells make energy and whether the medicine helps the heart work better by improving its response to insulin and reducing fat in and around the heart.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 30–70, sign and date a consent form, and agree to all study steps for the full study.
- Have a BMI of 27.5–40. BMI is a measure of weight compared with height.
- Have an HbA1c of 6.5–10%, a measure of average blood sugar, and blood pressure no higher than 145/65.
- Have an eGFR above 45, a blood test estimate of how well your kidneys work.
- Have heart failure with preserved ejection fraction (HFpEF): a heart ultrasound must show that your heart pumps out more than 50% of its blood with each beat. Have NYHA class II–III heart failure, meaning symptoms limit physical activity.
- Have type 2 diabetes treated only with diet and exercise, metformin, a sulfonylurea, metformin plus a sulfonylurea, a DPP-4 inhibitor, or insulin.
- If you can become pregnant, use highly effective birth control for at least 1 month before screening, during the study, and for 4 weeks afterward.
- If you can father a child, use condoms or another method to ensure effective birth control with your partner.
Who can't join
- Have a history of osteoporosis (weak bones) or proliferative diabetic retinopathy (eye damage from diabetes with abnormal blood vessel growth).
- Have heart failure caused by certain heart muscle diseases, active heart muscle swelling, a stiff sac around the heart, severe heart valve disease, or similar causes.
- Have symptoms from disease in the blood vessels that supply the heart.
- Have major changes in water pill treatment in the month before screening, meaning the dose doubled or another heart failure medicine was added.
- Take a GLP-1 receptor agonist, thiazolidinedione, or SGLT2 inhibitor. These are types of diabetes medicines.
- Are pregnant or breastfeeding.
- Have a known allergy to any part of the study treatments.
- Have metal plates, parts, screws, shrapnel, or pins in your body, or a heart pacemaker.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 30-70 years 4. Body Mass Index (BMI) of 27.5-40kg/m² 5. HbA1c of 6.5 to 10% 6. Blood pressure of less than or equal to 145/65mmHg 7. eGFR greater than 45 ml/min/1.73m² 8. Subject must have HFpEF (EF \> 50% by ECHO screening) 9. NYHA class II-III heart failure 10. Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied. 11. 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. 12. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: 1. Subjects with history of osteoporosis or proliferative diabetic retinopathy 2. Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded 3. Patients with symptomatic coronary artery disease. 4. 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). 5. Subjects treated with a GLP-1 RA or thiazolidinedione. 6. Subjects treated with a SGLT2i 7. Pregnancy or lactation 8. Known allergic reactions to components of the study interventions. 9. Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
Study sites (1)
TX
- Texas Diabetes Institute/UH · San Antonio, TX 78229-3900Ralph DeFronzo, MD · Study contact · 210-358-7200 · defronzo@uthscsa.eduSivaram Neppala, MD · Study contact · 210-358-7200 · neppalas@uthscsa.eduRalph DeFronzo, MD · Principal investigatorSivaram Neppala, MD · Sub-investigatorMore trials in San Antonio