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

Not Applicable

Completed

• Conditions: Ketosis; Diabetes Mellitus
• Interventions: Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB)

• Registration Number: NCT05518448
• Lead Sponsor: University of Exeter

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.

Study Timeline

• Study Start: 2022-05-03
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Primary Completion: 2022-12-02
• Study Completion: 2023-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone	Ketone - beta-hydroxybutyrate (β-OHB)	Ketone monester (beta-hydroxybutyrate (β-OHB)
Placebo	Ketone - beta-hydroxybutyrate (β-OHB)	Non-caloric placebo

Primary Outcome Measures

Name	Time	Method
EGP	6 hours	Endogenous glucose production

Secondary Outcome Measures

Name	Time	Method
Plasma β-OHB	6 hours	Plasma β-OHB concentrations
Postprandial glycemia	4 hours	Postprandial glucose concentrations
Insulin	6 hours	Serum insulin concentration

Trial Locations

Locations (1)

Sport & Health Sciences, University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom