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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 metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis.
The hypotheses are:
The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 3 hours of continuously intravenous infusion of 3-hydroxybutyrate. |
|
| Control | Placebo Comparator | 3 hours of continuously intravenous infusion of saline (NaCl). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-hydroxybutyrate | Biological | 3-hydroxybutyrate is a metabolite, produced in the human body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in lipolysis rate | Measured as differences in palmitate flux | After 3 hours of interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in protein metabolism | Measured as differences in forearm and whole body tracer kinetics | After 3 hours of interventions |
| Changes in glucose kinetics | Measured by glucose tracer. |
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Patients with type 1 diabetes:
Inclusion Criteria:
Exclusion Criteria:
Healthy control subjects:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Møller, Professor | Department of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital | Study Director |
| Maj Bangshaab, MD | Steno Diabetes Center Aarhus and Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno diabetes center Aarhus | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40210728 | Derived | Bangshaab M, Svart MV, Rittig N, Pedersen MGB, Voigt J, Jessen N, Moller N. Metabolic effects of 3-hydroxybutyrate infusion in individuals with type 1 diabetes compared with healthy control participants: a randomised crossover trial showing intact feedback suppression of lipolysis. Diabetologia. 2025 Jul;68(7):1390-1402. doi: 10.1007/s00125-025-06423-5. Epub 2025 Apr 10. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D016883 | Diabetic Ketoacidosis |
| 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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Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.
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| After 3 hours of interventions |
| Cardiac function | Changes in cardiac output and left ventricular ejection fraction measured by echocardiography | After 2-3 hours of interventions |
| Changes in signaling in muscle and adipose tissue | Western blot examinations of muscle and adipose tissue biopsies | After 1,5-3 hours of interventions |
| Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide | Blood samples | During the 3 hours intervention period |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D048909 | Diabetes Complications |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| D007657 | Ketone Bodies |
| D007659 | Ketones |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |