Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 hemodynamics effect 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 cardiac function and exercise capacity in patients with HFpEF and T2D.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Experimental Hyperketonemia on Myocardial Metabolism

NCT02814474

Healthy Volunteers

COMPLETED EARLY_PHASE1

Pre-meals of 3-hydroxybutyrate in Type 2 Diabetes

NCT05581043

Ketosis Postprandial Hyperglycemia Glucose Metabolism Disorders (Including Diabetes Mellitus)

COMPLETED NA

The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.

NCT01071772

Heart Failure Type 2 Diabetes

COMPLETED PHASE2

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

NCT03560323

Heart Failure Type 2 Diabetes Mellitus

COMPLETED PHASE1

Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes

NCT04009642

Diabetes Mellitus, Type 2 Metabolic Cardiomyopathy Metabolic Disturbance +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketone ester

Commercially available ketone supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo drink

Isocaloric placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes
* LVEF \> 40 %
* a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction
* age ≥ 18 years old,
* one of the following criteria (a-d) should be fulfilled:

1. Echocardiographic signs of diastolic dysfunction E/e' \> 8
2. Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s
3. Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm
4. NT-proBNP \> 125 pg/ml.