Relationship of Metabolic Syndrome and Its Components Wit... | NCT03009279

Studies
Relationship of Metabolic Syndrome and Its Components With Thyroid Nodule(s)

NCT03009279

Sponsor

Lin Liao

Status

Unknown status

Last Update Posted

Jan 9, 2017Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Metabolic Syndrome
Thyroid Nodule

Interventions

Not provided

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Nov 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 26, 2016

First Submission Date that Met QC Criteria

Dec 30, 2016

First Posted Date

Jan 4, 2017Estimated

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 5, 2017

Last Update Posted Date

Jan 9, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Liao, chief of endocrinology department at Qianfoshan Hospital, Qianfoshan HospitalSponsor-Investigator

Lead Sponsor

Lin LiaoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).

Detailed Description

To investigate the association between metabolic syndrome (MS), body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid nodule(s) or thyroid functions in euthyroid subjects. Screen for the risk factors that affect the incidence of thyroid nodule(s).

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The MS group		Patients with metabolic syndrome(MS).
The non-MS group		Patients without metabolic syndrome(MS).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The laboratory examinations	Lipids,glucose,thyroid functions	In 2013-2015

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure of patients in each group		In 2013-2015

Other Outcomes

Measure	Description	Time Frame
BMI of patients in each group	body mass index（BMI）	In 2013-2015
Age of patients in each group		In 2013-2015

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People who received routain physical and laboratory examinations in the Health Management Cenre of QianFoShan Hospital from Jan. 2013 to Dec. 2015.
signed the informed consent.
Have complete clinical data.

Exclusion Criteria:

Patients with previous history of thyroid disease other than thyroid nodules.
People with abnormal thyroid function.
Thyroid ultrasound revealed patients with other lesions other than normal thyroid and thyroid nodules.
Pregnant or lactating women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

People who received routain physical and laboratory examinations in the Health Management Cenre of QianFoShan Hospital from Jan. 2013 to Dec. 2015.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Liao, MD	Contact	8615168888260		liaolin@medmail.com.cn

Overall Officials

Name	Affiliation	Role
Lin Liao	Qianfoshan Hospital	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided