RecruitingEarly Phase 1NCT06108076

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


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

10 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking a special oral ketone supplement helps people who have both heart failure with reduced pumping ability (HFrEF) and diabetes. Researchers will use MRI scans and other tests to see how ketones affect heart and metabolic function. **You may be eligible if...** - You are between 18 and 80 years old - You have an established diagnosis of heart failure (confirmed by imaging in the last 6 months) and are on stable heart failure medications - You have a BMI between 23 and 38 - Your blood sugar (HbA1c) is between 6.0% and 10.0% - Your blood pressure is below 145/85 mmHg and your kidney function is adequate **You may NOT be eligible if...** - You are currently taking SGLT2 inhibitors (a type of diabetes medication) - You have had a cardiovascular event (heart attack, etc.) in the last 3 months - You are pregnant, breastfeeding, or planning to become pregnant - You have a history of most cancers (some exceptions apply) - You have significant organ problems that would interfere with completing the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetone Monoester (KE)

Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits


Locations(1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT06108076


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