Clinical trial NCT05263401: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Ketoses, Metabolic
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2022-03-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Postprandial P-glucose
timeFrame: 3 hours
Secondary outcomes:
measure: Postprandial free fatty acids (FFA)
timeFrame: 3 hours
measure: Differences in circulating concentrations of 3-hydroxybutyrate
timeFrame: 3,5 hours
measure: Lipolysis rate
timeFrame: 3 hours
measure: Glucose kinetics
timeFrame: 3 hours
measure: Gastric emptying
timeFrame: 3 hours
measure: Differences in hunger/satiety
timeFrame: 4 hours
measure: Differences in actual hunger
timeFrame: 30 minutes
measure: Differences in circulating concentrations of insulin
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of glucagon
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of c-peptide
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of ghrelin
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of cholecystokinin
timeFrame: 3,5 hours
measure: Differences in circulating concentrations of gastrin
timeFrame: 3,5 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical research laboratory, Department of endocrinology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Niels Møller, Professor
role: STUDY_DIRECTOR
References: