- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466697
Role of Dopamine Transporter in Glucose Control
April 19, 2022 updated by: Kyoungjune Pak, Pusan National University Hospital
Role of Dopamine Transporter in Glucose Loading of Healthy Subjects
Healthy subjects will be enrolled in this study.
Each subject will be scanned twice with F18-FP-CIT PET which is commercially available.
F18-FP-CIT reflects dopamine transporter availability of striatum.
Before each PET scan, subject will be injected either glucose or normal saline.
Therefore, PET scan will reflect the changes of dopamine transporter availability after the injection of glucose.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Busan, Korea, Republic of, 49241
- Pusan National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- known neurologic disorder
- known drug addiction
- known endocrine disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy subjects
All subjects will be injected twice for each visit (normal saline or glucose)
|
Before each PET scan, subject will be injected either glucose or normal saline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specific binding ratio of dopamine transporter availabilitiy measured from PET scans
Time Frame: less than 1 month
|
Specific binding ratio of dopamine transporter availabilitiy measured from PET scans
|
less than 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kyoungjune Pak, MD, PhD, Pusan National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2018
Primary Completion (Actual)
December 20, 2021
Study Completion (Actual)
December 20, 2021
Study Registration Dates
First Submitted
March 8, 2018
First Submitted That Met QC Criteria
March 13, 2018
First Posted (Actual)
March 15, 2018
Study Record Updates
Last Update Posted (Actual)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1707-019-057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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