Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes

NCT ID: NCT05263401

Last Updated: 2023-04-04

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-30

Brief Summary

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The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks.

The hypothesis is:

3-OHB as a pre-meal may:

* Lower postprandial blood glucose and lipids.
* Mediate release of intestinal hormones and affect gastric emptying.
* Affect appetite and other subjective measures related to food intake.

The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.

Detailed Description

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Conditions

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Type 2 Diabetes Ketoses, Metabolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ketone salt

Na-D/L-3-hydroxybutyrate dissolved in tap water.

Group Type EXPERIMENTAL

3-hydroxybutyrate

Intervention Type DIETARY_SUPPLEMENT

Orally administered pre-meal drinks.

Ketone ester

(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate

Group Type EXPERIMENTAL

3-hydroxybutyrate

Intervention Type DIETARY_SUPPLEMENT

Orally administered pre-meal drinks.

Placebo

Tap water

Group Type PLACEBO_COMPARATOR

3-hydroxybutyrate

Intervention Type DIETARY_SUPPLEMENT

Orally administered pre-meal drinks.

Interventions

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3-hydroxybutyrate

Orally administered pre-meal drinks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes diagnosis, metformin treated or dietary treated
* HbA1C \< 80 mmol/mol
* 25 \< BMI \< 35
* Written consent

Exclusion Criteria

* Severe comorbidity
* Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
* Specific diets, e.g. ketogenic diet
* PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Møller, Professor

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

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Medical research laboratory, Department of endocrinology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-282-20

Identifier Type: -

Identifier Source: org_study_id

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