Recruiting

Pioglitazone

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05838287

Conditions

Type 2 Diabetes Mellitus in Obese

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Interventions

Pioglitazone

Placebo

Study Details

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.

Conditions

Type 2 Diabetes Mellitus in Obese

Heart Failure With Preserved Ejection Fraction

Study ID

NCT05838287

Start date

Jul 10, 2023

Status verified date

Aug, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pioglitazone Administration Group

Pioglitazone 15mg/day titrated to 30 mg/day at week 2 and to 45 mg/day at week 4

placebo comparator: Placebo/Control Group

Placebo

Interventions

Pioglitazone

Participants will be taking Pioglitazone tablets 1/day for 24 weeks.

Placebo

Placebo for Pioglitazone

Primary outcome measure

  • Change in Systolic function [ Time Frame: Baseline and 6-months post treatment (approximately 24 weeks) ]
  • Change in Diastolic function [ Time Frame: Baseline and 6-months post treatment (approximately 24 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Texas Diabetes Institute/UH

Recruiting

San Antonio, Texas, United States, 78229-3900

Contacts

Principal Investigator:

Ralph DeFronzo, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-08-27.