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Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

The University of Texas Health Science Center at San Antonio · NCT05838287

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
78
US sites recruiting
1
Study start
July 10, 2023
Record last updated
September 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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:

  • 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.
  • 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.

Being studied: Pioglitazone; Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Texas Diabetes Institute/UH

    San Antonio, TX 78229-3900

    Site contact: Ralph DeFronzo, MD · 210-358-7200 · defronzo@uthscsa.edu

Study contacts (from the official record)

  • Sivaram Neppala, MD · 210-358-7200 · neppalas@uthscsa.edu
  • Andrea Hansis-Diarte, MPH · 210-567-3208 · Hansisdiarte@uthscsa.edu
All weight loss studies in Texas →
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants (NCT05838287) | Bored Studies