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

NCT06647368 | Recruiting

• 1 other identifier: GluCoMet_pilotA
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Glucose Metabolism

Outcome Measures

Primary Outcomes (1)

• Tmax correlation

  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.

  From administration of 180MBq 18-FDG and during the approximately first 15 min of the brain PET scan

Secondary Outcomes (1)

• CMRglc correlation

  From administration of 180MBq 18-FDG and during the 40 min brain PET scan

Study Arms (1)

PET with 18-FDG

EXPERIMENTAL

Other: PET with 18-FDG

Interventions

PET with 18-FDG OTHER

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.

PET with 18-FDG

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
• Body mass index \<= 25 kg/m\^2

You may not qualify if:

• 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:
• 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 Physiology and Nuclear Medicine, University of Copenhagen - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Lisbeth Marner, MD PhD

  University Hospital Bispebjerg and Frederiksberg

  STUDY CHAIR

• Nicolai J Wewer Albrecthsen, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina L Hansen, MD

CONTACT

004521205944; nina.lerberg.hansen.01@regionh.dk

Sasha Alexandra S Kjeldsen, MSc PhD

CONTACT

sasha.alexandra.sampson.kjeldsen@regionh.dk

Study Design

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

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 17, 2024
• Study Start: October 22, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

DK (1)