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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05263401
Other study ID # 1-10-72-282-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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