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

NCT ID: NCT05518448

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2023-11-01

Brief Summary

What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.

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.

Conditions

Diabetes Mellitus; Ketosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Ketone

Ketone monester (beta-hydroxybutyrate (β-OHB)

Group Type: EXPERIMENTAL

Ketone - beta-hydroxybutyrate (β-OHB)

Intervention Type: DIETARY_SUPPLEMENT

Ketone - beta-hydroxybutyrate (β-OHB)

Placebo

Non-caloric placebo

Group Type: PLACEBO_COMPARATOR

Ketone - beta-hydroxybutyrate (β-OHB)

Intervention Type: DIETARY_SUPPLEMENT

Ketone - beta-hydroxybutyrate (β-OHB)

Interventions

Ketone - beta-hydroxybutyrate (β-OHB)

Ketone - beta-hydroxybutyrate (β-OHB)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sport & Health Sciences, University of Exeter

Exeter, Devon, United Kingdom

Countries

United Kingdom

References

Monteyne AJ, Falkenhain K, Whelehan G, Neudorf H, Abdelrahman DR, Murton AJ, Wall BT, Stephens FB, Little JP. A ketone monoester drink reduces postprandial blood glucose concentrations in adults with type 2 diabetes: a randomised controlled trial. Diabetologia. 2024 Jun;67(6):1107-1113. doi: 10.1007/s00125-024-06122-7. Epub 2024 Mar 14.

Reference Type: DERIVED

PMID: 38483543 (View on PubMed)

Other Identifiers

22-02-02-B-01

Identifier Type: -

Identifier Source: org_study_id