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)

NCT ID: NCT05159570

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-06-15

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketone ester

Group Type EXPERIMENTAL

Ketone ester

Intervention Type DIETARY_SUPPLEMENT

Commercially available ketone supplement

Placebo

Group Type PLACEBO_COMPARATOR

Placebo drink

Intervention Type DIETARY_SUPPLEMENT

Isocaloric placebo

Interventions

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Ketone ester

Commercially available ketone supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo drink

Isocaloric placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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00550

Identifier Type: -

Identifier Source: org_study_id

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