Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants (PIOHF)
Type 2 Diabetes Mellitus in Obese, Heart Failure With Preserved Ejection Fraction
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus in Obese
Eligibility Criteria
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
Sites / Locations
- Texas Diabetes Institute/UHRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Pioglitazone Administration Group
Placebo/Control Group
Pioglitazone 15mg/day titrated to 30 mg/day at week 2 and to 45 mg/day at week 4
Placebo