The Effect of Glucagon on Cerebral Glucose Metabolism in Healthy Humans

NCT06877208 | Active Not Recruiting

• 1 other identifier: GluCoMet_pilotCD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study in which the investigators will investigate the effect of exogenous glucagon on cerebral glucose metabolism in healthy humans. Participants will participate in either part C or part D of the study, and each participant will participate in three study days. During a study day the participant will receive an intravenous infusion of either glucagon, glucose (in an adjustable rate to match to glucose concentrations achieved with the glucagon infusion) or saline. During each study day an 18F-flouro-deoxy-glucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) scan will be performed to quantify cerebral glucose metabolism during the first part (acute effect) of the glucagon/glucose/saline infusion (part C) or the last part (later effect) of the glucagon/glucose/saline infusion (part D).

Conditions

Cerebral Glucose Metabolism

Keywords

Glucagon; 18F-FDG PET; Quantitative PET; Cerebral Glucose Metabolism; Blood-brain Glucose Transfer

Outcome Measures

Primary Outcomes (1)

• Cerebral metabolic rate of glucose (CMRglc), acute effect (part C)

  CMRglc is calculated based on the 18F-FDG PET/CT scan.

  15-55 minutes

Secondary Outcomes (5)

• Cerebral metabolic rate of glucose (CMRglc), later effect (part D)

  150-190 minutes

• Blood-brain glucose transfer capacity (Tmax), acute effect (part C)

  15-55 minutes

• Blood-brain glucose transfer capacity (Tmax), later effect (part D)

  150-190 minutes

• FDG net clearance (Ki), acute effect (part C)

  15-55 minutes

• FDG net clearance (Ki), later effect (part D)

  150-190 minutes

Study Arms (6)

Acute effect (part C): Glucagon, Saline and Glucose Clamp

EXPERIMENTAL

The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp. An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.

Other: Glucagon (part C); Other: Glucose clamp (part C); Other: Saline (part C)

Acute effect (part C): Saline, Glucagon and Glucose Clamp

EXPERIMENTAL

The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp. An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.

Other: Glucagon (part C); Other: Glucose clamp (part C); Other: Saline (part C)

Acute effect (part C): Glucagon, Glucose Clamp and Saline

EXPERIMENTAL

The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline. An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.

Other: Glucagon (part C); Other: Glucose clamp (part C); Other: Saline (part C)

Later effect (part D): Glucagon, Saline and Glucose Clamp

EXPERIMENTAL

The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp. An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.

Other: Glucagon (part D); Other: Glucose clamp (part D); Other: Saline (part D)

Later effect (part D): Saline, Glucagon and Glucose Clamp

EXPERIMENTAL

The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp. An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.

Other: Glucagon (part D); Other: Glucose clamp (part D); Other: Saline (part D)

Later effect (part D): Glucagon, Glucose Clamp and Saline

EXPERIMENTAL

The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline. An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.

Other: Glucagon (part D); Other: Glucose clamp (part D); Other: Saline (part D)

Interventions

Glucagon (part C) OTHER

90 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min).

Acute effect (part C): Glucagon, Glucose Clamp and Saline; Acute effect (part C): Glucagon, Saline and Glucose Clamp; Acute effect (part C): Saline, Glucagon and Glucose Clamp

Glucose clamp (part C) OTHER

90 minutes intravenous infusion of 20 % weight/volume glucose (in an ajustable rate to match the glucose levels achieved during the glucagon infusion).

Acute effect (part C): Glucagon, Glucose Clamp and Saline; Acute effect (part C): Glucagon, Saline and Glucose Clamp; Acute effect (part C): Saline, Glucagon and Glucose Clamp

Saline (part C) OTHER

90 minutes intravenous infusion with isotonic NaCl.

Acute effect (part C): Glucagon, Glucose Clamp and Saline; Acute effect (part C): Glucagon, Saline and Glucose Clamp; Acute effect (part C): Saline, Glucagon and Glucose Clamp

Glucagon (part D) OTHER

210 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min).

Later effect (part D): Glucagon, Glucose Clamp and Saline; Later effect (part D): Glucagon, Saline and Glucose Clamp; Later effect (part D): Saline, Glucagon and Glucose Clamp

Glucose clamp (part D) OTHER

210 minutes intravenous infusion of 20 % weight/volume glucose (in an ajustable rate to match the glucose levels achieved during the glucagon infusion).

Later effect (part D): Glucagon, Glucose Clamp and Saline; Later effect (part D): Glucagon, Saline and Glucose Clamp; Later effect (part D): Saline, Glucagon and Glucose Clamp

Saline (part D) OTHER

210 minutes intravenous infusion with isotonic NaCl.

Later effect (part D): Glucagon, Glucose Clamp and Saline; Later effect (part D): Glucagon, Saline and Glucose Clamp; Later effect (part D): Saline, Glucagon and Glucose Clamp

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 to 70 years
• BMI under or equal to 30 kg/m2
• Capable of understanding the participant information and signing the consent form

You may not qualify if:

• Enrolment in other research projects that might interfere with the study
• Diabetes diagnosis (type 1 and 2)
• Use of medications which, in the opinion of the investigator, may jeopardise participant's safety or compliance with the protocol
• Diagnosis of psychiatric disorders, dementias, or any other neurological disorders that in the opinion of the investigator precludes compliance with the study protocol, evaluation of the results or represents an unacceptable risk for the participants safety
• Severe claustrophobia
• Impaired liver og kidney function
• Cardiac problems including any of the following:
• Classified as being in New York Heart Association (NYHA) class III or IV
• Angina pectoris (chest pain) within the last 6 months
• Acute myocardial infarction (heart attack) within last 2 years
• 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
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Glucagon; Glucose Clamp Technique; Sodium Chloride

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nicolai J Wewer Albrecthsen, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Lisbeth J Marner, MD PhD

  University Hospital Bispebjerg and Frederiksberg

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 18, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DK (1)