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PIOHF: Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05838287
Collaborator
(none)
78
Enrollment
1
Location
2
Arms
68.1
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Either Pioglitazone or Placebo Pioglitazone will be administered during this study in this Type 2 Diabetic population with Heart Failure to examine if there are any beneficial effects on diastolic and systolic function.

Myocardial blood flow (MBF) is measured using a PET scan, then participants will be randomized to pioglitazone or a placebo to examine the effects of the study drug on the effects on the systolic and diastolic function of the heart. In addition, myocardial insulin sensitivity change will be measured as well as myocardial fat content. The ratio of ATP: PCr will also be measured.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double-blind placebo controlled, randomized clinical trialdouble-blind placebo controlled, randomized clinical trial
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Neither the participant nor the investigator knows what treatment is given
Primary Purpose:
Treatment
Official Title:
Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2028
Anticipated Study Completion Date :
Jan 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pioglitazone Administration Group

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

Drug: Pioglitazone
Participants will be taking Pioglitazone tablets 1/day for 24 weeks.
Other Names:
  • Actos

    		•
    Placebo Comparator: Placebo/Control Group

    Placebo

    Drug: Placebo
    Placebo for Pioglitazone
    Other Names:
  • Placebo tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Systolic function [Baseline and 6-months post treatment (approximately 24 weeks)]

      Measurement of change in systolic function of the heart using cardiac MRI

    2. Change in Diastolic function [Baseline and 6-months post treatment (approximately 24 weeks)]

      Measurement of change in diastolic function of the heart using cardiac MRI

    Secondary Outcome Measures

    1. Myocardial insulin sensitivity [Baseline and 6-months post treatment (approximately 24 weeks)]

      Measurement of change in Free Plasma Glucose (FPG) in blood plasma

    2. Myocardial fat content [Baseline and 6-months post treatment (approximately 24 weeks)]

      Measurement of change in myocardial fat content

    3. PCr:ATP ratio [Baseline and 6-months post treatment (approximately 24 weeks)]

      Measurement of change in PCr:ATP ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Texas Diabetes Institute/UH San Antonio Texas United States 78229-3900

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Ralph DeFronzo, MD, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05838287
    Other Study ID Numbers:
    • HSC20220916H
    First Posted:
    May 1, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Pioglitazone

    Study Results

    No Results Posted as of May 1, 2023