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Recruiting Not applicable

Development of a Non-invasive Method for Quantifying Cerebral Glucose Metabolism for Studying the Effect of Glucagon in Humans

NCT06647368 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-10-22
Last updated
2024-10-17

Condition(s) studied

Cerebral Glucose Metabolism

Investigational drug(s) / intervention(s)

PET with 18-FDG

PET with 18-FDG: The intervention is a 1,5 hour PET scan, which will be performed in three steps (heart scan, brain scan and heart scan) and administration of radioactively labelled glucose (18-FDG) in two doses.

Study summary

The aim of the study is to develop a non-invasive method for quantifying cerebral glucose metabolism by PET scans in humans. This method will be used in subsequent studies, where the effect of the pancreatic hormone glucagon on cerebral glucose metabolism will be studied.

The golden standard for quantifying cerebral glucose metabolism by PET scans is based on arterial blood sampling, which complicates research setup. This study will investigate if image derived measurements instead of arterial blood samples can be used to quantify cerebral glucose metabolism.

We will compare the calculations of cerebral glucose metabolism based on arterial blood samples and image derived measurements and hopefully these will correlate.

Healthy participants will be included, and each participant will participate in one study day, which includes intravenous administration of radioactively labelled glucose (18-FDG), arterial blood sampling and PET scans.

Eligibility

Sex
ALL
Min age
25 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Capable of understanding the participant information and signing the consent form * Between 25 and 70 years of age * Body mass index \<= 25 kg/m\^2 Exclusion Criteria: * Enrolment in other research project that might interfere with the study * Diabetes diagnosis * 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 * 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 * 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

Primary outcome measure(s)

  • Tmax correlation — From administration of 180MBq 18-FDG and during the approximately first 15 min of the brain PET scan
    Difference between the blood-brain glucose transfer capacity (Tmax) calculated based on the image derived input function and Tmax calculated based on the arterial input funcion.

Trial sites (1)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06647368 on ClinicalTrials.gov ↗ ← All trials in Denmark