NCT05838287 Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
| NCT ID | NCT05838287 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Type 2 Diabetes Mellitus in Obese |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2023-07-10 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2023-07-10 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Ralph A DeFronzo, MD
PRINCIPAL INVESTIGATOR
University of Texas
Frequently Asked Questions
Who can join the NCT05838287 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 70 Years, studying Type 2 Diabetes Mellitus in Obese. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05838287 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05838287 currently recruiting?
Yes, NCT05838287 is actively recruiting participants. Contact the research team at neppalas@uthscsa.edu for enrollment information.
Where is the NCT05838287 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT05838287 clinical trial?
NCT05838287 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Ralph A DeFronzo, MD at University of Texas. The trial plans to enroll 78 participants.
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