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)

October 6, 2023 updated by: University of Aarhus

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo drink
Isocaloric placebo
Experimental: Ketone ester
Dietary supplement: Ketone ester
Commercially available ketone supplement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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