Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
NCT05236335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-10-10
Summary
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).
In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.
Conditions
- Heart Failure With Preserved Ejection Fraction
- Diabetes Mellitus, Type 2
- Ketonemia
Interventions
- DIETARY_SUPPLEMENT
-
Ketone ester
Commercially available ketone supplement
- DIETARY_SUPPLEMENT
-
Placebo drink
Isocaloric placebo
Sponsors & Collaborators
-
University of Aarhus
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2023-06-15
- Completion
- 2023-06-15
Countries
- Denmark
Study Locations
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