Weight Change, BodyNCT03146429
Prediction of Future Weight Change With Dopamine Transporter
An observational study of Weight Change, Body, run by Pusan National University Hospital.
Trial summary
This is the re-analyzing study of observational study by Parkinson's Progression Markers Initiative Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Change, Body
- What is being tested?
- I-123 FP-CIT Single photon emission tomography
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Apr 2017
- Phase
- Observational
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of 192 healthy controls with screening 123I-FP-CIT SPECT.
Who may be able to join
- males or females with their age of 30 years or older at screening
Who cannot join
- subjects with a neurological disorder, a first degree relative with idiopathic PD, Montreal Cognitive Assessment score of 26 or less, medications that might interfere with DAT SPECT scans, anticoagulants that might preclude safe completion of the lumbar puncture, or investigational drugs, and a condition that precludes the safe performance of routine lumbar puncture
About this study
This is the re-analyzing study of observational study by Parkinson's Progression Markers Initiative
- Conditions
- Weight Change, Body
- Being tested
- I-123 FP-CIT Single photon emission tomography
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-123 FP-CIT Single photon emission tomographyDiagnostic test
Brain scan for dopamine transporter
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
weight change per year until 5 years after SPECT
Measured: 1, 2, 3, 4, 5 year after SPECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jan 2017
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Change, BodyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146429
- Sponsor's protocol ID
- PusanNUH-2017
- Status last verified
- Apr 2018
- First submitted
- 7 May 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Future Weight Change With Dopamine Transporter
- ClinicalTrials.gov ID
- NCT03146429
- Acronym / sponsor ID
- PusanNUH-2017
- Conditions
- Weight Change, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 10 May 2017 (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.
This is the re-analyzing study of observational study by Parkinson's Progression Markers Initiative
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 192 healthy controls with screening 123I-FP-CIT SPECT.
Key inclusion criteria (1 listed)
- males or females with their age of 30 years or older at screening
Key exclusion criteria (1 listed)
- subjects with a neurological disorder, a first degree relative with idiopathic PD, Montreal Cognitive Assessment score of 26 or less, medications that might interfere with DAT SPECT scans, anticoagulants that might preclude safe completion of the lumbar puncture, or investigational drugs, and a condition that precludes the safe performance of routine lumbar puncture
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 |
|---|---|---|
| I-123 FP-CIT Single photon emission tomographyBrain scan for dopamine transporter | Diagnostic test | – |
Primary outcome
Weight change
Time frame: 1, 2, 3, 4, 5 year after SPECT
weight change per year until 5 years after SPECT
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 24 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Change, Body, run by Pusan National University Hospital.
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 1 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight change (time frame: 1, 2, 3, 4, 5 year after SPECT). 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 24 Apr 2018.