NCT03466697

Brief 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. Therefore, PET scan will reflect the changes of dopamine transporter availability after the injection of glucose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

March 8, 2018

Last Update Submit

April 19, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Specific binding ratio of dopamine transporter availabilitiy measured from PET scans

    Specific binding ratio of dopamine transporter availabilitiy measured from PET scans

    less than 1 month

Study Arms (1)

Healthy subjects

OTHER

All subjects will be injected twice for each visit (normal saline or glucose)

Other: Glucose injection/Normal saline injection

Interventions

Glucose injection/Normal saline injectionOTHER

Before each PET scan, subject will be injected either glucose or normal saline.

Healthy subjects

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • known neurologic disorder
  • known drug addiction
  • known endocrine disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

Location

MeSH Terms

Conditions

Obesity

Interventions

GlucoseSaline Solution

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kyoungjune Pak, MD, PhD

    Pusan National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 15, 2018

Study Start

March 14, 2018

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)