Prediction of Future Weight Change With Dopamine Transporter | NCT03146429

Studies
Prediction of Future Weight Change With Dopamine Transporter

NCT03146429

Sponsor

Pusan National University Hospital

Status

Completed

Last Update Posted

Apr 24, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Weight Change, Body

Interventions

I-123 FP-CIT Single photon emission tomography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017

Primary Completion Date

Apr 15, 2017Actual

Completion Date

Apr 15, 2017Actual

First Submitted Date

May 7, 2017

First Submission Date that Met QC Criteria

May 7, 2017

First Posted Date

May 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2018

Last Update Posted Date

Apr 24, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kyoungjune Pak, Clinical Assistant Professor, Pusan National University HospitalPrincipal Investigator

Lead Sponsor

Pusan National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
I-123 FP-CIT Single photon emission tomography	Diagnostic Test	Brain scan for dopamine transporter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight change	weight change per year until 5 years after SPECT	1, 2, 3, 4, 5 year after SPECT

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males or females with their age of 30 years or older at screening

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population consisted of 192 healthy controls with screening 123I-FP-CIT SPECT.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001836	Body Weight Changes

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided