Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Description

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

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Study Overview

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Study Details

Study overview

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.

Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)

Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Condition
Type 2 Diabetes Mellitus in Obese
Intervention / Treatment

-

Contacts and Locations

San Antonio

Texas Diabetes Institute/UH, San Antonio, Texas, United States, 78229-3900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

30 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Ralph A DeFronzo, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

2029-01