The Glucose-Independent Effects of Exogenous Glucagon on Insulin Secretion and Cognitive Function in Healthy Subjects

NCT06685146 | Completed

• 1 other identifier: GluCoMet_pilotB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will investigate the glucose-independent effects of exogenous glucagon on insulin secretion and cognitive function in healthy subjects. Subjects will participate in two study days. The first study day is with a 240-minute infusion of glucagon and the second study day is with an infusion of glucose (clamped to match the glucose levels measured during the glucagon infusion). During the study day, blood samples will be drawn frequently and cognitive testing will be performed. The investigators will investigate glucagon's glucose-independent effects on insulin secretion and cognitive function by comparing plasma measures of C-peptide and cognitive test scores between the glucagon study day and the glucose clamp study day.

Conditions

Glucose Metabolism; Insulin Secretion

Keywords

Glucagon; Glucose Metabolism; Cognition; Glucose clamp; Insulin secretion; C-peptide

Outcome Measures

Primary Outcomes (1)

• C-peptide (0-90 minutes)

  Difference in plasma concentrations of C-peptide assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day

  During intervention (0-90 minutes)

Secondary Outcomes (19)

• C-peptide to glucose ratio (0-90 minutes)

  During intervention (0-90 minutes)

• C-peptide to glucose ratio (0-240 minutes)

  During intervention (0-240 minutes)

• C-peptide (0-240 minutes)

  During intervention (0-240 minutes)

• C-peptide (0 minutes-glucose peak)

  During intervention (0-time to plasma glucose peak concentration (assessed up to two hours))

• C-peptide deconvolution (0-240 minutes)

  During intervention (0-240 minutes)

Other Outcomes (6)

• Word recall cognitive test

  During intervention (180-240 minutes)

• Three-letter recall cognitive test

  During intervention (180-240 minutes)

• Verbal fluency cognitive test

  During intervention (180-240 minutes)

Study Arms (1)

Glucagon infusion followed by glucose-clamp

EXPERIMENTAL

The first study day is a 240 minutes infusion of glucagon (10ng/kg/min). The second study day is a 240 minutes infusion of glucose (20% w/v). The infusion rate of glucose will be adjusted continuously to match the levels of glucose measured on the glucagon study day.

Other: Glucagon Infusion; Other: Glucose clamp

Interventions

Glucagon Infusion OTHER

A 240 minutes infusion of glucagon (10 ng/kg/min)

Glucagon infusion followed by glucose-clamp

Glucose clamp OTHER

A 240 minutes infusion of 20 % w/v glucose. The infusion rate of glucose will be adjusted continuously to match the levels of glucose measured on the glucagon study day.

Glucagon infusion followed by glucose-clamp

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• A minimum of 7 years of schooling

You may not qualify if:

• 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
• 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 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
• 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
• Inability to perform neuropsychological tests judged by the investigator (e.g. visual or auditory impairment or language barriers)

Sponsors & Collaborators

• Nicolai Jacob Wewer Albrechtsen: lead

Study Sites (1)

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

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Glucose Clamp Technique

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Nicolai J Wewer Albrecthsen, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: November 8, 2024
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DK (1)