Role of Dopamine Transporter in Glucose Control | NCT03466697

Studies
Role of Dopamine Transporter in Glucose Control

NCT03466697

Sponsor

Pusan National University Hospital

Status

Completed

Last Update Posted

Apr 20, 2022Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Glucose injection/Normal saline injection

Countries

South Korea

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 2022

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

Mar 14, 2018Actual

Primary Completion Date

Dec 20, 2021Actual

Completion Date

Dec 20, 2021Actual

First Submitted Date

Mar 8, 2018

First Submission Date that Met QC Criteria

Mar 13, 2018

First Posted Date

Mar 15, 2018Actual

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 19, 2022

Last Update Posted Date

Apr 20, 2022Actual

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

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy subjects	Other	All subjects will be injected twice for each visit (normal saline or glucose)	Other: Glucose injection/Normal saline injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose injection/Normal saline injection	Other	Before each PET scan, subject will be injected either glucose or normal saline.	Healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects

Exclusion Criteria:

known neurologic disorder
known drug addiction
known endocrine disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyoungjune Pak, MD, PhD	Pusan National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Hospital		Busan		49241	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose
D000077330	Saline Solution

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D000077324

Browse Leaves

Not provided

Browse Branches

Not provided