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

Launched by NICOLAI JACOB WEWER ALBRECHTSEN · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of glucagon, a hormone that helps regulate blood sugar levels, on insulin secretion and cognitive function in healthy people. Researchers want to see how glucagon affects these areas without the influence of glucose. Participants will take part in two separate study days: one where they receive a glucagon infusion for four hours, and another with a glucose infusion that matches the blood sugar levels from the first day. During both days, blood samples will be taken frequently, and participants will complete cognitive tests to measure any changes in their thinking abilities.

To be eligible for this study, participants should be between 25 and 70 years old, have a body mass index (BMI) of 25 or less, and have completed at least seven years of education. It's important to note that people with diabetes, certain medical conditions, or those who are pregnant or breastfeeding cannot participate. If you join the study, you can expect to undergo health screenings, receive infusions, and complete tests over two days, while contributing valuable information to help researchers understand how glucagon works.

Gender

ALL

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
• • A minimum of 7 years of schooling
• 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
• • 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:
• • 1. Classified as being in New York Heart Association (NYHA) class III or IV
• • 2. Angina pectoris (chest pain) within the last 6 months
• • 3. 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)
• • 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