The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes (KES2)
Primary Purpose
Diabetes Mellitus, Ketosis
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ketone - beta-hydroxybutyrate (β-OHB)
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus focused on measuring Diabetes, Exogenous ketones, Postprandial glycemia, Endogenous glucose production
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
Sites / Locations
- Sport & Health Sciences, University of ExeterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketone
Placebo
Arm Description
Ketone monester (beta-hydroxybutyrate (β-OHB)
Non-caloric placebo
Outcomes
Primary Outcome Measures
EGP
Endogenous glucose production
Secondary Outcome Measures
Postprandial glycemia
Postprandial glucose concentrations
Insulin
Serum insulin concentration
Plasma β-OHB
Plasma β-OHB concentrations
Full Information
NCT ID
NCT05518448
First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
University of Exeter
Collaborators
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05518448
Brief Title
The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
Acronym
KES2
Official Title
The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter
Collaborators
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Ketosis
Keywords
Diabetes, Exogenous ketones, Postprandial glycemia, Endogenous glucose production
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Ketone vs placebo crossover
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketone
Arm Type
Experimental
Arm Description
Ketone monester (beta-hydroxybutyrate (β-OHB)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Non-caloric placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone - beta-hydroxybutyrate (β-OHB)
Intervention Description
Ketone - beta-hydroxybutyrate (β-OHB)
Primary Outcome Measure Information:
Title
EGP
Description
Endogenous glucose production
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Postprandial glycemia
Description
Postprandial glucose concentrations
Time Frame
4 hours
Title
Insulin
Description
Serum insulin concentration
Time Frame
6 hours
Title
Plasma β-OHB
Description
Plasma β-OHB concentrations
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis Stephens, Phd
Phone
+44 (0)1392 72 2157
Email
F.B.Stephens@exeter.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alistair Monteyne, Phd
Email
a.monteyne2@exeter.ac.uk
Facility Information:
Facility Name
Sport & Health Sciences, University of Exeter
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Stephens, PhD
Phone
+44 (0)1392 72 2157
Email
F.B.Stephens@exeter.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes
We'll reach out to this number within 24 hrs