Clinical trial NCT06921824: Investigating the Acute Effects of Increasing Glucagon Exposure in Healthy Participants
Official title: Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glucose Metabolism
Glucagon
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators will investigate the acute effects of increasing glucagon 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.

Detailed description: Ten participants with normal health will be included, and each participant will participate in one study day.

Participants will arrive after an overnight fast and will be placed in a hospital bed in a semi-recumbent position. In each antecubital vein an intravenous catheter will be placed; one for administration of glucagon and one for blood sampling.

Two baseline blood samples will be drawn before the glucagon infusion is started. The glucagon infusion rate will be increased every 30 minutes (infusion rates are 0,01 ng/kg/min, 0,1 ng/kg/min, 0,5 ng/kg/min, 1,0 ng/kg/min, 10 ng/kg/min and 50 ng/kg/min).

Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.

Eligibility criteria: 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

Primary outcomes:
measure: Glucagon infusion rate that increases plasma glucose
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Glucagon infusion rate that increases plasma cAMP
timeFrame: 0-180 minutes
measure: Glucagon infusion rate that decreases plasma amino acids
timeFrame: 0-180 minutes
measure: Glucagon infusion rate that affects plasma triglycerides
timeFrame: 0-180 minutes
measure: Glucagon infusion rate that affects plasma nonesterified fatty acids
timeFrame: 0-180 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
name: Nicolai J Wewer Albrecthsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: