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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Ketoses, Metabolic
• Interventions: Dietary Supplement: 3-hydroxybutyrate

• Registration Number: NCT05263401
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone salt	3-hydroxybutyrate	Na-D/L-3-hydroxybutyrate dissolved in tap water.
Placebo	3-hydroxybutyrate	Tap water
Ketone ester	3-hydroxybutyrate	(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate

Primary Outcome Measures

Name	Time	Method
Postprandial P-glucose	3 hours	Incremental area under the curve (iAUC) for P-glucose.

Secondary Outcome Measures

Name	Time	Method
Gastric emptying	3 hours	Paracetamol test
Differences in circulating concentrations of cholecystokinin	3,5 hours	Blood samples
Postprandial free fatty acids (FFA)	3 hours	Blood samples
Differences in actual hunger	30 minutes	Ad libitum meal test
Differences in circulating concentrations of c-peptide	3,5 hours	Blood samples
Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)	3,5 hours	Blood samples
Glucose kinetics	3 hours	Glucose tracer examinations
Differences in circulating concentrations of glucagon	3,5 hours	Blood samples
Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)	3,5 hours	Blood samples
Differences in circulating concentrations of ghrelin	3,5 hours	Blood samples
Differences in circulating concentrations of gastrin	3,5 hours	Blood samples
Differences in circulating concentrations of 3-hydroxybutyrate	3,5 hours	Blood samples
Lipolysis rate	3 hours	Measures of palmitate flux (palmitate tracer)
Differences in hunger/satiety	4 hours	Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10
Differences in circulating concentrations of insulin	3,5 hours	Blood samples

Trial Locations

Locations (1)

Medical research laboratory, Department of endocrinology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark