Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
Recruiting · NCT05838287 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center at San Antonio
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Texas Diabetes Institute/UH - San Antonio, Texas, United States