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

U

University of Exeter

Status

Enrolling

Conditions

Ketosis
Diabetes Mellitus

Treatments

Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB)

Study type

Interventional

Funder types

Other

Identifiers

NCT05518448
22-02-02-B-01

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups, including a placebo group

Ketone
Experimental group
Description:
Ketone monester (beta-hydroxybutyrate (β-OHB)
Treatment:
Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB)
Placebo
Placebo Comparator group
Description:
Non-caloric placebo
Treatment:
Dietary Supplement: Ketone - beta-hydroxybutyrate (β-OHB)

Trial contacts and locations

0

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Central trial contact

Alistair Monteyne, Phd; Francis Stephens, Phd

Data sourced from clinicaltrials.gov

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