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Completed

NCT Number: NCT05263401

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

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.

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Key information

Conditions

Type 2 Diabetes Acid-Base Imbalance Acidosis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Ketoses, Metabolic Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical research laboratory, Department of endocrinology, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3-hydroxybutyrate

Dietary Supplement

Orally administered pre-meal drinks.

Primary outcomes

  1. Postprandial P-glucose

    Time frame: 3 hours

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

Secondary outcomes

  1. Postprandial free fatty acids (FFA)

    Time frame: 3 hours

    Blood samples

  2. Differences in circulating concentrations of 3-hydroxybutyrate

    Time frame: 3,5 hours

    Blood samples

  3. Lipolysis rate

    Time frame: 3 hours

    Measures of palmitate flux (palmitate tracer)

  4. Glucose kinetics

    Time frame: 3 hours

    Glucose tracer examinations

  5. Gastric emptying

    Time frame: 3 hours

    Paracetamol test

  6. Differences in hunger/satiety

    Time frame: 4 hours

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

  7. Differences in actual hunger

    Time frame: 30 minutes

    Ad libitum meal test

  8. Differences in circulating concentrations of insulin

    Time frame: 3,5 hours

    Blood samples

  9. Differences in circulating concentrations of glucagon

    Time frame: 3,5 hours

    Blood samples

  10. Differences in circulating concentrations of c-peptide

    Time frame: 3,5 hours

    Blood samples

  11. Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1)

    Time frame: 3,5 hours

    Blood samples

  12. Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP)

    Time frame: 3,5 hours

    Blood samples

  13. Differences in circulating concentrations of ghrelin

    Time frame: 3,5 hours

    Blood samples

  14. Differences in circulating concentrations of cholecystokinin

    Time frame: 3,5 hours

    Blood samples

  15. Differences in circulating concentrations of gastrin

    Time frame: 3,5 hours

    Blood samples

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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