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Oral Ketones for Heart Failure

Q: Does this trial permit participation from individuals below the age of 65?

Those who meet the age criteria (over 18 and under 80) are eligible to join this clinical trial.

Q: What is the current participant count for this research endeavor?

Affirmative. The details listed on clinicaltrials.gov reveal that the trial is presently recruiting volunteers, with its initial posting being dated November 1st 2023 and its most recent edit occurring on 26th October 2023. There are plans to enroll 10 people at one site for this study.

Q: Are there still vacancies for study participants?

Correct. Data hosted on clinicaltrials.gov shows that this medical research, which was originally posted on November 1st 2023, is currently recruiting volunteers. Approximately 10 participants need to be welcomed at a single site.

Q: What are the main aims of this clinical experiment?

This clinical trial seeks to measure Cardiac Efficiency levels over a period of between 90 minutes and 24 hours as its primary outcome. Additionally, Acetoacetate, Glucose, and Free Fatty Acid Baseline-to-7 day level comparisons are noted as secondary objectives.

Q: Is eligibility for this medical trial open to applicants?

Candidates must be between 18 and 80 years old, have <a href="https://www.withpower.com/clinical-trials/type-2-diabetes">type 2 diabetes</a>, and meet additional criteria to qualify for this clinical trial. The aim is to enroll 10 participants in total.

Phase < 1

Recruiting

Led By Carolina Solis-Herrera, 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

Age = 18-80 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 hours to 24 hours

Awards & highlights

Study Summary

This trial will study if taking ketone esters can improve heart function in people with T2DM and heart failure.

Who is the study for?

Adults aged 18-80 with Type 2 Diabetes and Heart Failure (HFrEF), having a BMI of 23-38, stable heart medications, and functioning kidneys. Women must agree to use contraception. Excluded are those with recent cardiovascular events, certain drug treatments for diabetes or heart issues, pregnancy, substance abuse problems, major diseases that limit study participation or a history of cancer (except certain skin cancers in remission).Check my eligibility

What is being tested?

The trial is testing the effects of an oral supplement called Ketone Monoester on heart function in patients with both Type 2 Diabetes and HFrEF. It aims to understand if this supplement can change how the heart works by providing it with ketones that don't rely on insulin.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions to ingredients in the Ketone Monoester or other unforeseen responses due to its interaction with existing conditions like diabetes and HFrEF.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 hours to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 hours to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 hours to 24 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cardiac Efficiency after acute dose (Left-ventricular function)

Cardiac Efficiency after chronic dosing (Left-ventricular function)

Secondary outcome measures

Acetoacetate

Beta-hydroxybutyrate

Free Fatty Acids (FFAs)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketone Ester administrationExperimental Treatment1 Intervention

Monitored administration of oral Ketone monoester at 400mg/kg dosed twice on visit 2 (cardiac MRI day) Self administered oral β-hydroxybutyrate (BOHB) at 400mg/kg/day for a period of 6 days

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

322 Previous Clinical Trials

401,753 Total Patients Enrolled

1 Trials studying Heart Failure

30 Patients Enrolled for Heart Failure

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,420 Total Patients Enrolled

6 Trials studying Heart Failure

305 Patients Enrolled for Heart Failure

Carolina Solis-Herrera, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Heart Failure

30 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

Does this trial permit participation from individuals below the age of 65?

"Those who meet the age criteria (over 18 and under 80) are eligible to join this clinical trial."

Answered by AI

What is the current participant count for this research endeavor?

"Affirmative. The details listed on clinicaltrials.gov reveal that the trial is presently recruiting volunteers, with its initial posting being dated November 1st 2023 and its most recent edit occurring on 26th October 2023. There are plans to enroll 10 people at one site for this study."

Answered by AI

Are there still vacancies for study participants?

"Correct. Data hosted on clinicaltrials.gov shows that this medical research, which was originally posted on November 1st 2023, is currently recruiting volunteers. Approximately 10 participants need to be welcomed at a single site."

Answered by AI

What are the main aims of this clinical experiment?

"This clinical trial seeks to measure Cardiac Efficiency levels over a period of between 90 minutes and 24 hours as its primary outcome. Additionally, Acetoacetate, Glucose, and Free Fatty Acid Baseline-to-7 day level comparisons are noted as secondary objectives."

Answered by AI

Is eligibility for this medical trial open to applicants?

"Candidates must be between 18 and 80 years old, have type 2 diabetes, and meet additional criteria to qualify for this clinical trial. The aim is to enroll 10 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes

2024. "Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108076.