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NCT05159570 Clinical Trial

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)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05159570
Other study ID # 00550
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date June 15, 2023

Study information
Verified date December 2021
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ketone ester
Commercially available ketone supplement
• Placebo drink
Isocaloric placebo

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in lipolysis rate Measured as differences in palmitate flux After 14 days treatment
Secondary Changes in glucose kinetic Measured by glucose tracer. After 14 days treatment
Secondary Changes in signaling in muscle and adipose tissue After 14 days treatment
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