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Investigating the Acute Effects of Increasing Glucagon Exposure in Healthy Participants

N

Nicolai Jacob Wewer Albrechtsen

Status

Completed

Conditions

Glucose Metabolism
Glucagon

Treatments

Other: Glucagon

Study type

Interventional

Funder types

Other

Identifiers

NCT06921824
GluCoMet_stepwise glucagon

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Glucagon Infusion
Experimental group
Treatment:
Other: Glucagon

Trial contacts and locations

1

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Central trial contact

Sasha Alexander S Kjeldsen, MSc PhD; Nina Hansen, MD

Data sourced from clinicaltrials.gov

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