Tests pioglitazone in obese adults with diabetes and heart failure
Tests pioglitazone against placebo in obese adults with diabetes and heart failure.
Plain-language title generated from the registry record
Registry title: Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Key facts
- Where
- San Antonio, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 70 years old?
Source: NCT05838287, who can take part
Where in United States
- Texas Diabetes Institute/UHSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center at San Antonio
- Trial code
- NCT05838287
- Record updated
- 22 September 2026
- Original 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:Read full original descriptionShow less
Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Inclusion: 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: 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; 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; Known allergic reactions to components of the study interventions; Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker; Pregnancy or lactation.