Type 2 Diabetes Mellitus in ObesePhase 4PIOHFNCT05838287
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
A Phase 4 study testing Pioglitazone in people with Type 2 Diabetes Mellitus in Obese and Heart Failure With Preserved Ejection Fraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to Jan 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 30-70 years
- Body Mass Index (BMI) of 27.5-40kg/m²
- HbA1c of 6.5 to 10%
- Blood pressure of less than or equal to 145/65mmHg
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- eGFR greater than 45 ml/min/1.73m²
- Subject must have HFpEF (EF > 50% by ECHO screening)
- NYHA class II-III heart failure
- Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
- 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.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Who cannot join
- Subjects with history of osteoporosis or proliferative diabetic retinopathy
- Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
- Patients with symptomatic coronary artery disease.
- 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).
- Subjects treated with a GLP-1 RA or thiazolidinedione.
- Subjects treated with a SGLT2i
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- Pregnancy or lactation
- Known allergic reactions to components of the study interventions.
- Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Diabetes Institute/UH
San Antonio, Texas, 78229-3900
Ralph DeFronzo, MD, 210-358-7200, defronzo@uthscsa.edu
Sivaram Neppala, MD, 210-358-7200, neppalas@uthscsa.edu
About this study
Official title: Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)
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:
- 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.
- 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.
Read the 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.
- Being tested
- Pioglitazone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Participants will be taking Pioglitazone tablets 1/day for 24 weeks.
PlaceboDrug
Also called Placebo tablet
Placebo for Pioglitazone
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone Administration Group | Active comparator | Pioglitazone 15mg/day titrated to 30 mg/day at week 2 and to 45 mg/day at week 4 Receives: Drug: Pioglitazone |
| Placebo/Control Group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic function
Measurement of change in systolic function of the heart using cardiac MRI
Measured: 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
Measured: Baseline and 6-months post treatment (approximately 24 weeks)
Secondary outcomes (3)
Myocardial insulin sensitivity
Measurement of change in Free Plasma Glucose (FPG) in blood plasma
Measured: Baseline and 6-months post treatment (approximately 24 weeks)
Myocardial fat content
Measurement of change in myocardial fat content
Measured: Baseline and 6-months post treatment (approximately 24 weeks)
PCr:ATP ratio
Measurement of change in PCr:ATP ratio
Measured: Baseline and 6-months post treatment (approximately 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start10 Jul 2023
- Primary completionAug 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind placebo controlled, randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph A DeFronzo, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838287
- Sponsor's protocol ID
- HSC20220916H
- Acronym
- PIOHF
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be available to other researchers.