Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Phase 4

Recruiting

• Conditions: Type 2 Diabetes Mellitus in Obese; Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT05838287
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-4-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Provision of signed and dated informed consent form<br><br> 2. Stated willingness to comply with all study procedures and availability for the<br> duration of the study<br><br> 3. Male or female, aged 30-70 years<br><br> 4. Body Mass Index (BMI) of 27.5-40kg/m²<br><br> 5. HbA1c of 6.5 to 10%<br><br> 6. Blood pressure of less than or equal to 145/65mmHg<br><br> 7. eGFR greater than 45 ml/min/1.73m²<br><br> 8. Subject must have HFpEF (EF > 50% by ECHO screening)<br><br> 9. NYHA class II-III heart failure<br><br> 10. Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU,<br> DPP4i or insulin will be studied.<br><br> 11. For females of reproductive potential: use of highly effective contraception for at<br> least 1 month prior to screening and agreement to use such a method during study<br> participation and for an additional [4 weeks] after the end of study participation.<br><br> 12. For males of reproductive potential: use of condoms or other methods to ensure<br> effective contraception with partner.<br><br>Exclusion Criteria:<br><br> 1. Subjects with history of osteoporosis or proliferative diabetic retinopathy<br><br> 2. Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy,<br> active myocarditis, constrictive pericarditis, severe valvular heart disease, etc.<br> will be excluded<br><br> 3. Patients with symptomatic coronary artery disease.<br><br> 4. Subjects with significant change in diuretic management during the month prior to<br> screening (defined by doubling of diuretic dose, or addition of another HF<br> medication).<br><br> 5. Subjects treated with a GLP-1 RA or thiazolidinedione.<br><br> 6. Subjects treated with a SGLT2i<br><br> 7. Pregnancy or lactation<br><br> 8. Known allergic reactions to components of the study interventions.<br><br> 9. Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart)<br> pacemaker

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Systolic function;Change in Diastolic function

Secondary Outcome Measures

Name	Time	Method
Myocardial insulin sensitivity;Myocardial fat content;PCr:ATP ratio