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

Diabetes Mellitus Clinical Trial

— KES2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518448
• Other study ID #: 22-02-02-B-01
• Status: Completed
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2024
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Ketosis

Intervention

Dietary Supplement:
• Ketone - beta-hydroxybutyrate (ß-OHB)
Ketone - beta-hydroxybutyrate (ß-OHB)

Locations

Country	Name	City	State
United Kingdom	Sport & Health Sciences, University of Exeter	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	University of British Columbia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGP	Endogenous glucose production	6 hours
Secondary	Postprandial glycemia	Postprandial glucose concentrations	4 hours
Secondary	Insulin	Serum insulin concentration	6 hours
Secondary	Plasma ß-OHB	Plasma ß-OHB concentrations	6 hours