Investigating the Acute Effects of Increasing Alanine Exposure in Healthy Participants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorNicolai Jacob Wewer Albrechtsen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Capable of understanding the participant information and signing the consent form
Between 25 and 70 years of age at the time of screening
Body mass index (BMI) ≤ 25 kg/m2 at the time of screening
Disqualifiers
Enrolment in other research projects that might interfere with the study
Diabetes diagnosis (type 1 and 2)
Pregnancy or breastfeeding
Use of medications which, in the opinion of the investigator, may jeopardise participant's safety or compliance with the protocol
Trial design
Design model
Single group
Treatments tested in this trial
alanine
Other interventionA three-hour intravenous infusion with alanine with increasing infusion rate (from 1.4 μmol/kg/min and to 28 μmol/kg/min)
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Alanine infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Threshold alanine infusion rate for stimulation of plasma glucagon
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.Secondary outcomes
1
Change in plasma glucose during stepwise alanine infusion
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.2
Change in plasma follicle-stimulating hormone (FSH) during stepwise alanine infusion
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.3
Change in plasma luteinizing hormone (LH) during stepwise alanine infusion
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.4
Change in plasma cortisol during stepwise alanine infusion
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicolai Jacob Wewer Albrechtsen
Lead sponsor
University of Copenhagen
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: