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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05159570

Enrollment

Registered

2021-12-16

Start date

2023-02-01

Completion date

2023-06-15

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTKetone ester

Commercially available ketone supplement

DIETARY_SUPPLEMENTPlacebo drink

Isocaloric placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Differences in lipolysis rate	After 14 days treatment	Measured as differences in palmitate flux

Secondary

Measure	Time frame	Description
Changes in glucose kinetic	After 14 days treatment	Measured by glucose tracer.
Changes in signaling in muscle and adipose tissue	After 14 days treatment	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026