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

Primary Purpose

Metabolic Syndrome, Thyroid Nodule

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Lin Liao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Metabolic Syndrome focused on measuring blood pressure, fasting plasma glucose, thyroid stimulating hormone

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Arm Label

    The MS group

    The non-MS group

    Arm Description

    Patients with metabolic syndrome(MS).

    Patients without metabolic syndrome(MS).

    Outcomes

    Primary Outcome Measures

    The laboratory examinations
    Lipids,glucose,thyroid functions

    Secondary Outcome Measures

    Blood pressure of patients in each group

    Full Information

    First Posted
    December 26, 2016
    Last Updated
    January 5, 2017
    Sponsor
    Lin Liao
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03009279
    Brief Title
    Relationship of Metabolic Syndrome and Its Components With Thyroid Nodule(s)
    Official Title
    Relationship of Metabolic Syndrome and Its Components With Thyroid Nodule(s)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lin Liao

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Thyroid Nodule
    Keywords
    blood pressure, fasting plasma glucose, thyroid stimulating hormone

    7. Study Design

    Enrollment
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The MS group
    Arm Description
    Patients with metabolic syndrome(MS).
    Arm Title
    The non-MS group
    Arm Description
    Patients without metabolic syndrome(MS).
    Primary Outcome Measure Information:
    Title
    The laboratory examinations
    Description
    Lipids,glucose,thyroid functions
    Time Frame
    In 2013-2015
    Secondary Outcome Measure Information:
    Title
    Blood pressure of patients in each group
    Time Frame
    In 2013-2015
    Other Pre-specified Outcome Measures:
    Title
    BMI of patients in each group
    Description
    body mass index（BMI）
    Time Frame
    In 2013-2015
    Title
    Age of patients in each group
    Time Frame
    In 2013-2015
    Title
    Gender of patients in each group
    Time Frame
    In 2013-2015

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Study Population Description
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lin Liao, MD
    Phone
    8615168888260
    Email
    liaolin@medmail.com.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lin Liao
    Organizational Affiliation
    Qianfoshan Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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