The Association Between Autoimmune or Inflammation and Th... | NCT02886949

Studies
The Association Between Autoimmune or Inflammation and Thyroid Disease

NCT02886949

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Jan 7, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

THYROTOXICOSIS

Interventions

Not provided

Countries

Taiwan

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Sep 2, 2015

First Submission Date that Met QC Criteria

Aug 26, 2016

First Posted Date

Sep 1, 2016Estimated

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

Jan 4, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study aims to evaluate the effects of thyroid functions on energy homeostasis and inflammation.

Detailed Description

The subjects were enrolled for evaluation of thyroid functions. The associations between thyroid function and energy homeostasis and inflammation will be assessed.

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

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
brain-derived neurotrophic factor	BDNF	3 months

Secondary Outcomes

Measure	Description	Time Frame
vascular cell adhesion molecule 1 (VCAM-1)	Inflammation	3 months
C-reactive protein (CRP)	Inflammation	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects visits outpatient department due to a suspicion of thyroid disease

Exclusion Criteria:

Psychological disorders, severe inflammatory or infection diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with a suspicion of thyroid disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
I-Te Lee, MD	Contact			itlee@vghtc.gov.tw

Overall Officials

Name	Affiliation	Role
I-Te Lee, MD	Taichung Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital	Recruiting	Taichang		407	Taiwan

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
D013971	Thyrotoxicosis

Ancestor Terms

ID	Term
D006980	Hyperthyroidism
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided