ObesityNCT03466697
Role of Dopamine Transporter in Glucose Control
A study testing Glucose injection/Normal saline injection in people with Obesity, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Glucose injection/Normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 2018to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
Who cannot join
- known neurologic disorder
- known drug addiction
- known endocrine disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Glucose injection/Normal saline injection
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose injection/Normal saline injectionOther
Before each PET scan, subject will be injected either glucose or normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | All subjects will be injected twice for each visit (normal saline or glucose) Receives: Other: Glucose injection/Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific binding ratio of dopamine transporter availabilitiy measured from PET scans
Specific binding ratio of dopamine transporter availabilitiy measured from PET scans
Measured: less than 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start14 Mar 2018
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoungjune Pak, Pusan National University Hospital
- Investigators
- Kyoungjune Pak, MD, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466697
- Sponsor's protocol ID
- 1707-019-057
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dopamine Transporter in Glucose Loading of Healthy Subjects
- ClinicalTrials.gov ID
- NCT03466697
- Acronym / sponsor ID
- 1707-019-057
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Other: Glucose injection/Normal saline injectionAll subjects will be injected twice for each visit (normal saline or glucose) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (3 listed)
- known neurologic disorder
- known drug addiction
- known endocrine disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose injection/Normal saline injectionBefore each PET scan, subject will be injected either glucose or normal saline. | Other | Healthy subjects |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoungjune Pak, MD, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose injection/Normal saline injection in people with Obesity, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific binding ratio of dopamine transporter availabilitiy measured from PET scans (time frame: less than 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.