The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes (KES2)

May 20, 2024 updated by: University of Exeter
What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.

Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.

Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.

Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.

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

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • Sport & Health Sciences, University of Exeter

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 to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications.
  • Non-smoking
  • Blood pressure <160/100 mm/Hg

Exclusion Criteria:

  • Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment.
  • Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements.
  • Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease.
  • Smoker
  • Blood pressure >160/100 mm/Hg
  • Lactose intolerant

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketone
Ketone monester (beta-hydroxybutyrate (β-OHB)
Dietary supplement: Ketone - beta-hydroxybutyrate (β-OHB)
Ketone - beta-hydroxybutyrate (β-OHB)
Placebo Comparator: Placebo
Non-caloric placebo
Dietary supplement: Ketone - beta-hydroxybutyrate (β-OHB)
Ketone - beta-hydroxybutyrate (β-OHB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EGP
Time Frame: 6 hours
Endogenous glucose production
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glycemia
Time Frame: 4 hours
Postprandial glucose concentrations
4 hours
Insulin
Time Frame: 6 hours
Serum insulin concentration
6 hours
Plasma β-OHB
Time Frame: 6 hours
Plasma β-OHB concentrations
6 hours

Collaborators and Investigators

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

Sponsor

University of Exeter

Collaborators

University of British Columbia

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)

May 3, 2022

Primary Completion (Actual)

December 2, 2022

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-02-02-B-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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