Trials / Recruiting
RecruitingNCT06647368
Development of a Non-invasive Method for Quantifying Cerebral Glucose Metabolism for Studying the Effect of Glucagon in Humans
Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot study_A
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Nicolai Jacob Wewer Albrechtsen · Academic / Other
- Sex
- All
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Participants will arrive after a four hour fast. An arterial cannulation will be placed in the radial or brachial artery for blood sampling. A venous catheter will be placed in the antecubital vein for administration of 18-FDG. Blood glucose is measured. Before administration of 18-FDG a "low dose" CT scan of the heart and brain will be performed. At time 0 minutes 20 MBq 18-FDG will be administered, 10 minutes automatic blood sampling (from the arterial cannulation) will be started and a 10 minutes three part dynamic PET scan of the heart will be performed. Approximately at time 20 minutes 180 MBq 18-FDG will be administered and a 40 minutes three part dynamic PET scan of the brain will be performed. During the first 10 minutes of the brain scan automatic blood sampling (from the arterial cannulation) will be performed and thereafter manual blood sampling will be performed every 5 minutes. After the 40 minutes brain PET scan a 5 min post scan of the heart will be performed. Radioactivity will be measured in the arterial blood samples and the results will be used for an Arterial Input Function (AIF). Radioactivity measurements derived from the heart scans will be used for an Image Derived Input Function (IDIF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2024-10-22
- Primary completion
- 2024-12-17
- Completion
- 2024-12-17
- First posted
- 2024-10-17
- Last updated
- 2024-10-17
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06647368. Inclusion in this directory is not an endorsement.