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

Type 2 Diabetes Clinical Trial

Official title:

3-hydroxybutyrate as a Meal Primer in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05263401
• Other study ID #: 1-10-72-282-20
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Ketoses, Metabolic
• Ketosis
• Type 2 Diabetes

Intervention

Dietary Supplement:
• 3-hydroxybutyrate
Orally administered pre-meal drinks.

Locations

Country	Name	City	State
Denmark	Medical research laboratory, Department of endocrinology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial P-glucose	Incremental area under the curve (iAUC) for P-glucose.	3 hours
Secondary	Postprandial free fatty acids (FFA)	Blood samples	3 hours
Secondary	Differences in circulating concentrations of 3-hydroxybutyrate	Blood samples	3,5 hours
Secondary	Lipolysis rate	Measures of palmitate flux (palmitate tracer)	3 hours
Secondary	Glucose kinetics	Glucose tracer examinations	3 hours
Secondary	Gastric emptying	Paracetamol test	3 hours
Secondary	Differences in hunger/satiety	Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10	4 hours
Secondary	Differences in actual hunger	Ad libitum meal test	30 minutes
Secondary	Differences in circulating concentrations of insulin	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of glucagon	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of c-peptide	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of ghrelin	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of cholecystokinin	Blood samples	3,5 hours
Secondary	Differences in circulating concentrations of gastrin	Blood samples	3,5 hours