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Clinical Trial Details

Trial ID: L1978
Source ID: NCT06108076
Associated Drug: Ketone Monoester (Ke)
Title: Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Heart Failure, Reduced Ejection Fraction
Interventions: DRUG: Ketone Monoester (KE)
Outcome Measures: Primary: Cardiac Efficiency after acute dose (Left-ventricular function), Change in cardiac efficiency after acute dosing of KE, measured by change in Left-ventricular function measured using Cardiac MRI and expressed as a percentage., 1.5 hours to 24 hours|Cardiac Efficiency after chronic dosing (Left-ventricular function), Change in cardiac efficiency after chronic (7 day) dosing of KE, measured by change in Left-Ventricular function measured using Cardiac MRI and expressed as a percentage., 1.5 hours to 7 days | Secondary: Six minute walk test, Participants will be asked to walk as far as possible for 6 minutes, escorted by a member of the research team. Baseline to 7 day distance will be compared., Baseline to 7 days|Acetoacetate, Baseline to 7 day level will be compared., Baseline to 7 days|Glucose, Baseline to 7 day level will be compared., Baseline to 7 days|Free Fatty Acids (FFAs), Baseline to 7 day level will be compared., Baseline to 7 days|Insulin/C-peptide, Baseline to 7 day level will be compared., Baseline to 7 days|Glucagon, Baseline to 7 day level will be compared., Baseline to 7 days|Beta-hydroxybutyrate, Baseline to 7 day level will be compared., Baseline to 7 days|Patient Reported Outcomes Measure Information System (PROMIS) - Physical Function, This tool is a well-developed and validated method to obtain self-reported parameters of health in adults, we will be using: PROMISĀ® Item Bank v2.0 - Physical Function - Short Form 20a Subjects will rank 20 questions from a scale of 1 - 5, with 5 being the highest physical function and 1 being the lowest. The score will be added up, and the Raw score will be converted to T-Score using the PROMIS Adult v2.0 Physical Function 20a Short Form Conversion Table. Baseline to 7 day T-Score will be compared, with a Higher T-Score indicating higher physical function., Baseline to 7 days
Sponsor/Collaborators: Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: National Center for Advancing Translational Sciences (NCATS)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: EARLY_PHASE1
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-16
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2025-02-03
Locations: University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT06108076