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NCT Number: NCT07350512

Investigating the Acute Effects of Increasing Alanine Exposure in Healthy Participants

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Copenhagen, Denmark

Location contact

Sophie BB Johnsen, MD

CONTACT

[email protected]

004521205944

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Impaired liver function defined as either alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) ≥ 2 times normal values
  • Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female
  • Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the range 90-150 mmHg for systolic and 50-100 mmHg for diastolic
  • Active or recent malignant disease
  • Current or history of severe alcohol use or drug/chemical abuse as per investigator's judgement
  • Any chronic disorders or severe diseases which, in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol

Treatment and study plan

alanine

Other

A three-hour intravenous infusion with alanine with increasing infusion rate (from 1.4 μmol/kg/min and to 28 μmol/kg/min)

Primary outcomes

  1. Threshold alanine infusion rate for stimulation of plasma glucagon

    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).

Secondary outcomes

  1. Change in plasma glucose during stepwise alanine infusion

    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.

  2. Change in plasma follicle-stimulating hormone (FSH) during stepwise alanine infusion

    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.

  3. Change in plasma luteinizing hormone (LH) during stepwise alanine infusion

    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.

  4. Change in plasma cortisol during stepwise alanine infusion

    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.

  5. Change in plasma triglycerides during stepwise alanine infusion

    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.

  6. Change in plasma urea during stepwise alanine infusion

    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.

  7. Change in plasma alanine aminotransferase (ALAT) during stepwise alanine infusion

    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.

  8. Change in plasma C-peptide during stepwise alanine infusion

    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.

  9. Change in plasma insulin during stepwise alanine infusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elvar Már Sturlaugsson Jóhönnuson, Stud. Med.

CONTACT

[email protected]

21205944 Ext. 0045

Sponsors and collaborators

Lead sponsor

Nicolai Jacob Wewer Albrechtsen

Other

Registry information

Official study title

Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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