NCT05159570

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Metabolic Effects. (KETO-HFpEF-Metabolic)

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Metabolic Effects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 effects 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 whole body and skeletal metabolism in patients with HFpEF and T2D.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Diabetes Mellitus, Type 2
• Ketonemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketone ester	Commercially available ketone supplement
DIETARY_SUPPLEMENT	Placebo drink	Isocaloric placebo

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2021-12-16
• Last updated: 2023-10-10

Locations

1 site across 1 country: Denmark