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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone salt | Experimental | Na-D/L-3-hydroxybutyrate dissolved in tap water. |
|
| Ketone ester | Experimental | (R)-3-Hydroxybutyl (R)-3-hydroxybutyrate |
|
| Placebo | Placebo Comparator | Tap water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-hydroxybutyrate | Dietary Supplement | Orally administered pre-meal drinks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial P-glucose | Incremental area under the curve (iAUC) for P-glucose. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial free fatty acids (FFA) | Blood samples | 3 hours |
| Differences in circulating concentrations of 3-hydroxybutyrate | Blood samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Møller, Professor | Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical research laboratory, Department of endocrinology, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41315088 | Derived | Bangshaab M, Bengtsen MB, Smedegaard S, Sondergaard E, Moller N, Svart MV, Rittig N. Ketone supplementation dose-dependently lowers postprandial blood glucose, lipid and ghrelin levels in individuals with type 2 diabetes: a randomised crossover study. Diabetologia. 2026 Mar;69(3):752-763. doi: 10.1007/s00125-025-06614-0. Epub 2025 Nov 28. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020155 | 3-Hydroxybutyric Acid |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| 3,5 hours |
| Lipolysis rate | Measures of palmitate flux (palmitate tracer) | 3 hours |
| Glucose kinetics | Glucose tracer examinations | 3 hours |
| Gastric emptying | Paracetamol test | 3 hours |
| Differences in hunger/satiety | Questionnaire for quantifying hunger/satiety on a VAS scale from 1-10 | 4 hours |
| Differences in actual hunger | Ad libitum meal test | 30 minutes |
| Differences in circulating concentrations of insulin | Blood samples | 3,5 hours |
| Differences in circulating concentrations of glucagon | Blood samples | 3,5 hours |
| Differences in circulating concentrations of c-peptide | Blood samples | 3,5 hours |
| Differences in circulating concentrations of Glucagon-like peptide-1 (GLP-1) | Blood samples | 3,5 hours |
| Differences in circulating concentrations of Gastric inhibitory polypeptide (GIP) | Blood samples | 3,5 hours |
| Differences in circulating concentrations of ghrelin | Blood samples | 3,5 hours |
| Differences in circulating concentrations of cholecystokinin | Blood samples | 3,5 hours |
| Differences in circulating concentrations of gastrin | Blood samples | 3,5 hours |
| D004700 | Endocrine System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| D007657 | Ketone Bodies |
| D007659 | Ketones |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |