Investigating the Acute Effects of Increasing Alanine Exposure in Healthy Participants

Nicolai Jacob Wewer Albrechtsen

Status

Not yet enrolling

Conditions

Glucagon

Glucose Metabolism

Treatments

Other: alanine

Study type

Interventional

Funder types

Other

Identifiers

NCT07350512

GluCoMet_stepwise alanine

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 estimated patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

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