Investigating the Acute Effects of Increasing Alanine Exposure in Healthy Participants

NCT07350512 | Not Yet Recruiting

• 1 other identifier: GluCoMet_stepwise alanine
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose Metabolism; Glucagon

Keywords

Alanine; glucagon; glucose metabolism

Outcome Measures

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).

  Baseline and every 30 minutes during the 0-180 min infusion period.

Secondary Outcomes (9)

• Change in plasma glucose during stepwise alanine infusion

  Baseline and every 30 minutes during the 0-180 min infusion period.

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

  Baseline and every 30 minutes during the 0-180 min infusion period.

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

  Baseline and every 30 minutes during the 0-180 min infusion period.

• Change in plasma cortisol during stepwise alanine infusion

  Baseline and every 30 minutes during the 0-180 min infusion period.

• Change in plasma triglycerides during stepwise alanine infusion

  Baseline and every 30 minutes during the 0-180 min infusion period.

Study Arms (1)

Alanine infusion

EXPERIMENTAL

Other: alanine

Interventions

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)

Alanine infusion

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolai Jacob Wewer Albrechtsen: lead

Study Sites (1)

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

Copenhagen, Denmark

Location

MeSH Terms

Interventions

Alanine

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Nicolai Jacob Wewer Albrechtsen, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elvar Már Sturlaugsson Jóhönnuson, Stud. Med.

CONTACT

21205944 Ext. 0045; elvar.mar.sturlaugsson@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

DK (1)