Steno diabetes center Aarhus
Aarhus, 8000, Denmark
NCT Number: NCT04656236
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:
1. 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes. 2. Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls. 3. 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls.
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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Notify Me18 year–60 year
Male
Interventional
Not applicable
Aarhus, 8000, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Patients with type 1 diabetes:
Inclusion criteria
Exclusion criteria
Healthy control subjects:
Inclusion criteria
Exclusion criteria
3-hydroxybutyrate is a metabolite, produced in the human body.
Time frame: After 3 hours of interventions
Measured as differences in palmitate flux
Time frame: After 3 hours of interventions
Measured as differences in forearm and whole body tracer kinetics
Time frame: After 3 hours of interventions
Measured by glucose tracer.
Time frame: After 2-3 hours of interventions
Changes in cardiac output and left ventricular ejection fraction measured by echocardiography
Time frame: After 1,5-3 hours of interventions
Western blot examinations of muscle and adipose tissue biopsies
Time frame: During the 3 hours intervention period
Blood samples
University of Aarhus
Other
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