RECRUITING

Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

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Conditions

Type 2 Diabetes Mellitus in ObeseHeart Failure With Preserved Ejection Fraction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-10
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838287

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.

Ages Eligible for Study:30 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, aged 30-70 years
  4. 4. Body Mass Index (BMI) of 27.5-40kg/m²
  5. 5. HbA1c of 6.5 to 10%
  6. 6. Blood pressure of less than or equal to 145/65mmHg
  7. 7. eGFR greater than 45 ml/min/1.73m²
  8. 8. Subject must have HFpEF (EF \> 50% by ECHO screening)
  9. 9. NYHA class II-III heart failure
  10. 10. Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
  11. 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. 12. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
  1. 1. Subjects with history of osteoporosis or proliferative diabetic retinopathy
  2. 2. Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
  3. 3. Patients with symptomatic coronary artery disease.
  4. 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. 5. Subjects treated with a GLP-1 RA or thiazolidinedione.
  6. 6. Subjects treated with a SGLT2i
  7. 7. Pregnancy or lactation
  8. 8. Known allergic reactions to components of the study interventions.
  9. 9. Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker

Contacts and Locations

Study Contact

Sivaram Neppala, MD
CONTACT
210-358-7200
neppalas@uthscsa.edu
Andrea Hansis-Diarte, MPH
CONTACT
210-567-3208
Hansisdiarte@uthscsa.edu

Principal Investigator

Ralph A DeFronzo, MD
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Ralph A DeFronzo, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10
Study Completion Date2029-01

Study Record Updates

Study Start Date2023-07-10
Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

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