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Thiazolidinedione

Pioglitazone for Heart Failure in Type 2 Diabetes (PIOHF Trial)

Phase 4

Recruiting

Led By Ralph DeFronzo, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.

eGFR greater than 45 ml/min/1.73m²

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6-months post treatment (approximately 24 weeks)

Awards & highlights

PIOHF Trial Summary

This trial tests if Pioglitazone can help type-2 diabetic obese patients with Heart failure by improving heart function and insulin sensitivity.

Who is the study for?

This trial is for obese individuals aged 30-70 with type-2 diabetes and heart failure (NYHA class II-III) who have an ejection fraction over 50%. Participants should be on certain diabetes medications but not on GLP-1 RA, thiazolidinedione, or SGLT2i. They must have stable heart medication use and no history of severe heart conditions unrelated to their diabetes.Check my eligibility

What is being tested?

The study tests Pioglitazone's effect on heart function in diabetic patients with heart failure. It aims to see if the drug can improve energy production in the heart by reducing fat around it and increasing insulin sensitivity. Half will receive Pioglitazone; the other half a placebo.See study design

What are the potential side effects?

Pioglitazone may cause fluid retention leading to swelling, weight gain, fatigue, bone fractures in women, bladder cancer risk increase after long-term use, and potential worsening of diabetic eye disease.

PIOHF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have type 2 diabetes and am treated with specific medications or diet/exercise.

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My kidney function is good.

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I am between 30 and 70 years old.

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I have moderate heart failure.

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My heart pumps well (EF > 50%).

PIOHF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6-months post treatment (approximately 24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6-months post treatment (approximately 24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6-months post treatment (approximately 24 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Diastolic function

Change in Systolic function

Secondary outcome measures

Myocardial fat content

Myocardial insulin sensitivity

PCr:ATP ratio

PIOHF Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Pioglitazone Administration GroupActive Control1 Intervention

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

Group II: Placebo/Control GroupPlacebo Group1 Intervention

Placebo

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,352 Total Patients Enrolled

5 Trials studying Heart Failure

227 Patients Enrolled for Heart Failure

Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas

11 Previous Clinical Trials

1,036 Total Patients Enrolled

2 Trials studying Heart Failure

101 Patients Enrolled for Heart Failure

Ralph A DeFronzo, MDPrincipal InvestigatorUniversity of Texas

9 Previous Clinical Trials

1,078 Total Patients Enrolled

1 Trials studying Heart Failure

78 Patients Enrolled for Heart Failure

Media Library

Pioglitazone (Thiazolidinedione) Clinical Trial Eligibility Overview. Trial Name: NCT05838287 — Phase 4

Heart Failure Research Study Groups: Pioglitazone Administration Group, Placebo/Control Group

Heart Failure Clinical Trial 2023: Pioglitazone Highlights & Side Effects. Trial Name: NCT05838287 — Phase 4

Pioglitazone (Thiazolidinedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838287 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment age for this experiment restricted to those over 25 years old?

"This medical trial is seeking patients between the age of 30 and 70 years old."

Answered by AI

To whom is this research opportunity available?

"This medical trial is seeking 78 participants between the ages of 30 and 70 who have been diagnosed with diabetes mellitus."

Answered by AI

Has the Pioglitazone Administration Group been approved by any government regulatory authorities?

"Our team at Power rated Pioglitazone Administration Group a 3, since this is a Phase 4 trial and the treatment has already been authorized."

Answered by AI

Is this trial currently enrolling participants?

"The clinicaltrials.gov registry states that this trial, first posted on May 1st 2023 and last updated April 20th, is not searching for any more patients right now. Subsequently, there are 2103 other studies actively seeking enrolment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

2023. "Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838287.