Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05838287
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Pioglitazone — DRUG
    Participants will be taking Pioglitazone tablets 1/day for 24 weeks.
  • Placebo — DRUG
    Placebo for Pioglitazone

Study Details

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.

Key Dates

Start date
Jul 10, 2023
Status verified
Aug 2025
Primary completion
Aug 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Diabetes Institute/UHSan AntonioTexas78229-3900
Ralph DeFronzo, MD
[email protected]
210-358-7200
Sivaram Neppala, MD
[email protected]
210-358-7200
Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR)
Sivaram Neppala, MD (SUB_INVESTIGATOR)

Find similar trials in San Antonio, TX

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Texas Diabetes Institute/UH· San Antonio, TX

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