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)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Heart Failure With Preserved Ejection Fraction; Ketonemia
• Interventions: Dietary Supplement: Placebo drink; Dietary Supplement: Ketone ester

• Registration Number: NCT05159570
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Study Start: 2023-02-01
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

(i) Type 2 diabetes, (ii) LVEF > 40 %, (iii) a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness > 12 mm) and/or previous myocardial infarction, (iiii) age ≥ 18 years old, and (iv) one of the following criteria (a-d) should be fulfilled:

Echocardiographic signs of diastolic dysfunction E/e' > 8 Septal e ́< 7 cm/s and/or lateral e ́ < 10 cm/s Left atrium volume index ≥34 mL/m2 and/or left atrial diameter > 4 cm NT-proBNP > 125 pg/ml.

Exclusion Criteria

• Insulin treatment, inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo drink	-
Ketone ester	Ketone ester	-

Primary Outcome Measures

Name	Time	Method
Differences in lipolysis rate	After 14 days treatment	Measured as differences in palmitate flux

Secondary Outcome Measures

Name	Time	Method
Changes in glucose kinetic	After 14 days treatment	Measured by glucose tracer.
Changes in signaling in muscle and adipose tissue	After 14 days treatment

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark