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

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05263401
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 14
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Ketoses, Metabolic	Dietary Supplement: 3-hydroxybutyrate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 3-hydroxybutyrate as a Meal Primer in Patients With Type 2 Diabetes
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketone salt Na-D/L-3-hydroxybutyrate dissolved in tap water.	Dietary Supplement: 3-hydroxybutyrate; Orally administered pre-meal drinks.
Experimental: Ketone ester (R)-3-Hydroxybutyl (R)-3-hydroxybutyrate	Dietary Supplement: 3-hydroxybutyrate; Orally administered pre-meal drinks.
Placebo Comparator: Placebo Tap water	Dietary Supplement: 3-hydroxybutyrate; Orally administered pre-meal drinks.

Outcome Measures

Primary Outcome Measures

1. Postprandial P-glucose [3 hours]

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

Secondary Outcome Measures

1. Postprandial free fatty acids (FFA) [3 hours]

   Blood samples

2. Differences in circulating concentrations of 3-hydroxybutyrate [3,5 hours]

   Blood samples

3. Lipolysis rate [3 hours]

   Measures of palmitate flux (palmitate tracer)

4. Glucose kinetics [3 hours]

   Glucose tracer examinations

5. Gastric emptying [3 hours]

   Paracetamol test

6. Differences in hunger/satiety [4 hours]

   Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10

7. Differences in actual hunger [30 minutes]

   Ad libitum meal test

8. Differences in circulating concentrations of insulin [3,5 hours]

   Blood samples

9. Differences in circulating concentrations of glucagon [3,5 hours]

   Blood samples

10. Differences in circulating concentrations of c-peptide [3,5 hours]

    Blood samples

11. Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1) [3,5 hours]

    Blood samples

12. Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP) [3,5 hours]

    Blood samples

13. Differences in circulating concentrations of ghrelin [3,5 hours]

    Blood samples

14. Differences in circulating concentrations of cholecystokinin [3,5 hours]

    Blood samples

15. Differences in circulating concentrations of gastrin [3,5 hours]

    Blood samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical research laboratory, Department of endocrinology, Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• Aarhus University Hospital

Investigators

• Study Director: Niels Møller, Professor, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT05263401
• Other Study ID Numbers: 1-10-72-282-20
• First Posted: Mar 2, 2022
• Last Update Posted: Apr 6, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Ketosis

Study Results

No Results Posted as of Apr 6, 2022