Investigating the Acute Effects of Increasing Glucagon Exposure in Healthy Participants

NCT ID: NCT06921824

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-09-19

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.

Conditions

Glucose Metabolism; Glucagon

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Glucagon Infusion

Group Type: EXPERIMENTAL

Glucagon

Intervention Type: OTHER

A three-hour intravenous infusion with glucagon with increasing infusion rate (from 0,01 ng/kg/min up to 50 ng/kg/min)

Interventions

Glucagon

A three-hour intravenous infusion with glucagon with increasing infusion rate (from 0,01 ng/kg/min up to 50 ng/kg/min)

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nicolai Jacob Wewer Albrechtsen

OTHER

Sponsor Role: lead

Responsible Party

Nicolai Jacob Wewer Albrechtsen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicolai J Wewer Albrecthsen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

GluCoMet_stepwise glucagon

Identifier Type: -

Identifier Source: org_study_id