Ketoses, Metabolic, Type 2 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENT3-hydroxybutyrate
Orally administered pre-meal drinks.
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial P-glucose | 3 hours | Incremental area under the curve (iAUC) for P-glucose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in circulating concentrations of glucagon | 3,5 hours | Blood samples |
| 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 |
| 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 cholecystokinin | 3,5 hours | Blood samples |
| Differences in circulating concentrations of gastrin | 3,5 hours | Blood samples |
| Differences in circulating concentrations of insulin | 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) |
| Glucose kinetics | 3 hours | Glucose tracer examinations |
| Gastric emptying | 3 hours | Paracetamol test |
| Differences in hunger/satiety | 4 hours | Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10 |
| Differences in actual hunger | 30 minutes | Ad libitum meal test |
| Postprandial free fatty acids (FFA) | 3 hours | Blood samples |
Countries
Denmark
Outcome results
None listed