Status:
RECRUITING
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Type 2 Diabetes
Heart Failure, Reduced Ejection Fraction
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
After the screening visit, subject will take two separate doses of oral ketones during visit two. Subjects will have their first dose (400mg/kg) upon completion of the baseline Magnetic Resonance Imag...
Eligibility Criteria
Inclusion
- Subjects must be on a stable dose of guideline-directed medications for Heart Failure (HF).
- Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months.
- Age = 18-80 y
- Body Mass Index (BMI) =23-38 kg/m2
- Glycated hemoglobin (HbA1c) = 6.0-10.0%
- Blood Pressure (BP) \< 145/85 mmHg
- Estimated Glomerular Filtration Rate (eGFR) \> 30 ml/min•1.73 m2
- For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.
Exclusion
- Patients treated with Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or acutely worsen glycemic control will be excluded.
- Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each Magnetic resonance imaging (MRI) study to assess current status.
- Allergy/sensitivity to study drugs or their ingredients.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Subjects with a history of cancer (except basal or squamous cell cancer that has been resolved/remission for 5 years)
- Cardiovascular event within the last 3 months
- Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06108076
Start Date
January 16 2024
End Date
December 31 2025
Last Update
February 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229