| Trial ID: | L6363 |
| Source ID: | NCT05838287
|
| Associated Drug: |
Pioglitazone
|
| Title: |
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
|
| Acronym: |
PIOHF
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus in Obese|Heart Failure With Preserved Ejection Fraction
|
| Interventions: |
DRUG: Pioglitazone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Systolic function, Measurement of change in systolic function of the heart using cardiac MRI, Baseline and 6-months post treatment (approximately 24 weeks)|Change in Diastolic function, Measurement of change in diastolic function of the heart using cardiac MRI, Baseline and 6-months post treatment (approximately 24 weeks) | Secondary: Myocardial insulin sensitivity, Measurement of change in Free Plasma Glucose (FPG) in blood plasma, Baseline and 6-months post treatment (approximately 24 weeks)|Myocardial fat content, Measurement of change in myocardial fat content, Baseline and 6-months post treatment (approximately 24 weeks)|PCr:ATP ratio, Measurement of change in PCr:ATP ratio, Baseline and 6-months post treatment (approximately 24 weeks)
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-07-10
|
| Completion Date: |
2029-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-20
|
| Locations: |
Texas Diabetes Institute/UH, San Antonio, Texas, 78229-3900, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05838287
|
