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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06108076
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketone Monoester (KE) — DRUG
    Ketones are a nutritional supplement currently used by athletes for their performance enhancing effects - specifically their cardio-pulmonary benefits

Study Details

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.

Key Dates

Start date
Jan 16, 2024
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Cardiac Efficiency after acute dose (Left-ventricular function) [ Time Frame: 1.5 hours to 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Carolina Solis-Herrera, MD
[email protected]
210-567-4900

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Texas Health Science Center at San Antonio· San Antonio, TX

Related Studies