NCT05838287RecruitingPhase 4
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 10 Apr 2023
- Start date
- 10 Jul 2023
- Primary completion date
- Aug 2029
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Heart failure, Obesity, Type 2 diabetes
- NCT number
- NCT05838287
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 78
- From 10 Jul 2023 to the primary completion date, Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Pregnancy or lactation
Who the study is looking for
- 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.
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Diabetes Institute/UH Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.