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Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Ketoses, Metabolic

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3-hydroxybutyrate
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes diagnosis, metformin treated or dietary treated
  • HbA1C < 80 mmol/mol
  • 25 < BMI < 35
  • Written consent

Exclusion Criteria:

  • Severe comorbidity
  • Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
  • Specific diets, e.g. ketogenic diet
  • PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)

Sites / Locations

  • Medical research laboratory, Department of endocrinology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ketone salt

Ketone ester

Placebo

Arm Description

Na-D/L-3-hydroxybutyrate dissolved in tap water.

(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate

Tap water

Outcomes

Primary Outcome Measures

Postprandial P-glucose
Incremental area under the curve (iAUC) for P-glucose.

Secondary Outcome Measures

Postprandial free fatty acids (FFA)
Blood samples
Differences in circulating concentrations of 3-hydroxybutyrate
Blood samples
Lipolysis rate
Measures of palmitate flux (palmitate tracer)
Glucose kinetics
Glucose tracer examinations
Gastric emptying
Paracetamol test
Differences in hunger/satiety
Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10
Differences in actual hunger
Ad libitum meal test
Differences in circulating concentrations of insulin
Blood samples
Differences in circulating concentrations of glucagon
Blood samples
Differences in circulating concentrations of c-peptide
Blood samples
Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)
Blood samples
Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)
Blood samples
Differences in circulating concentrations of ghrelin
Blood samples
Differences in circulating concentrations of cholecystokinin
Blood samples
Differences in circulating concentrations of gastrin
Blood samples

Full Information

First Posted
December 14, 2021
Last Updated
April 3, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05263401
Brief Title
Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes
Official Title
3-hydroxybutyrate as a Meal Primer in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

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
The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks. The hypothesis is: 3-OHB as a pre-meal may: Lower postprandial blood glucose and lipids. Mediate release of intestinal hormones and affect gastric emptying. Affect appetite and other subjective measures related to food intake. The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Ketoses, Metabolic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketone salt
Arm Type
Experimental
Arm Description
Na-D/L-3-hydroxybutyrate dissolved in tap water.
Arm Title
Ketone ester
Arm Type
Experimental
Arm Description
(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
3-hydroxybutyrate
Intervention Description
Orally administered pre-meal drinks.
Primary Outcome Measure Information:
Title
Postprandial P-glucose
Description
Incremental area under the curve (iAUC) for P-glucose.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Postprandial free fatty acids (FFA)
Description
Blood samples
Time Frame
3 hours
Title
Differences in circulating concentrations of 3-hydroxybutyrate
Description
Blood samples
Time Frame
3,5 hours
Title
Lipolysis rate
Description
Measures of palmitate flux (palmitate tracer)
Time Frame
3 hours
Title
Glucose kinetics
Description
Glucose tracer examinations
Time Frame
3 hours
Title
Gastric emptying
Description
Paracetamol test
Time Frame
3 hours
Title
Differences in hunger/satiety
Description
Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10
Time Frame
4 hours
Title
Differences in actual hunger
Description
Ad libitum meal test
Time Frame
30 minutes
Title
Differences in circulating concentrations of insulin
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of glucagon
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of c-peptide
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of ghrelin
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of cholecystokinin
Description
Blood samples
Time Frame
3,5 hours
Title
Differences in circulating concentrations of gastrin
Description
Blood samples
Time Frame
3,5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes diagnosis, metformin treated or dietary treated HbA1C < 80 mmol/mol 25 < BMI < 35 Written consent Exclusion Criteria: Severe comorbidity Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas Specific diets, e.g. ketogenic diet PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Møller, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Medical research laboratory, Department of endocrinology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes

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