Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen, Denmark
NCT Number: NCT07350512
In this study the investigators will investigate the acute effects of increasing alanine exposure on metabolic parameters in healthy participants.
Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. The infusion rate will be increased every 30 minutes.
Trial opening soon.
Get Notified25 year–70 year
All sexes
Interventional
Not applicable
Copenhagen, Denmark
Two peripheral catheters will be placed in the antecubital vein of each arm for infusion of L-alanine and blood sampling respectively. The infusion rate of alanine will start at 1.4 μmol/kg/min and increase every 30 minutes over a 3-hour period, up to a maximum of 28 μmol/kg/min. The study day will last approximately 4 hours, and a maximal blood volume of 130 ml will be collected. Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A three-hour intravenous infusion with alanine with increasing infusion rate (from 1.4 μmol/kg/min and to 28 μmol/kg/min)
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Lowest alanine infusion rate (µmol/kg/min) at which plasma glucagon concentration is significantly higher than baseline during a 3-hour stepwise alanine infusion (six 30-minute steps from 1.4 to 28 µmol/kg/min).
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma glucose concentration (mmol/L) measured at baseline and every 30 minutes during a 3-hour stepwise alanine infusion (1.4-28 µmol/kg/min), analyzed as absolute values and change from baseline.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma follicle-stimulating hormone (FSH) concentration (IU/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to explore acute effects on pituitary gonadotropin secretion.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma luteinizing hormone (LH) concentration (IU/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to explore acute effects on pituitary gonadotropin secretion.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma cortisol concentration (nmol/L) measured at baseline and every 60 minutes during the 3-hour stepwise alanine infusion to assess activation of the hypothalamic-pituitary-adrenal axis.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma triglyceride concentration (mmol/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to evaluate acute effects on lipid metabolism.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma urea (carbamide) concentration (mmol/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to assess short-term effects on nitrogen metabolism.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma alanine aminotransferase (ALAT/ALT) activity (U/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to assess acute changes in liver enzyme levels.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma C-peptide concentration (pmol/L) measured at baseline and every 30 minutes during a 3-hour stepwise alanine infusion, analyzed as absolute values and change from baseline.
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Plasma insulin concentration (pmol/L) measured at baseline and every 30 minutes during a 3-hour stepwise alanine infusion, analyzed as absolute values and change from baseline.
Contact information is provided by the study sponsor or research team.
Nicolai Jacob Wewer Albrechtsen
Other
Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study
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