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)
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2021
CompletedFirst Posted
Study publicly available on registry
December 16, 2021
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedOctober 10, 2023
December 1, 2021
4 months
December 2, 2021
October 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in lipolysis rate
Measured as differences in palmitate flux
After 14 days treatment
Secondary Outcomes (2)
Changes in glucose kinetic
After 14 days treatment
Changes in signaling in muscle and adipose tissue
After 14 days treatment
Study Arms (2)
Ketone ester
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- Insulin treatment, inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2021
First Posted
December 16, 2021
Study Start
February 1, 2023
Primary Completion
June 15, 2023
Study Completion
June 15, 2023
Last Updated
October 10, 2023
Record last verified: 2021-12