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Evaluation of Innovated Screening Tools for Type 2 Diabetes Among Chinese Population(SENSIBLE STUDY I)

Sponsor
Zhongda Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03025919
Collaborator
(none)
20,000
Enrollment
1
Location
11
Duration (Months)
1822.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Using 2h-glycosuria Combined With Fasting Plasma Glucose , Advanced Glycation End-product Alone or in Combination With Fasting Plasma Glucose in Diabetes Screening in Chinese Natural Population
    Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Jun 1, 2017
    Study Completion Date :
    Dec 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. area under the ROC curve [6 months]

      area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population

    Secondary Outcome Measures

    1. sensitivity and specificity of screening [6 months]

      Using WHO criteria as golden standard,sensitivity and specificity of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 20~70 year old urban and rural residents;

    • Volunteer to participate in this study and sign informed consent.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University Nanjing Jiangsu China

    Sponsors and Collaborators

    • Zhongda Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zilin Sun, director physician, Zhongda Hospital
    ClinicalTrials.gov Identifier:
    NCT03025919
    Other Study ID Numbers:
    • 2016YFC1305700s
    First Posted:
    Jan 20, 2017
    Last Update Posted:
    May 8, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Zilin Sun, director physician, Zhongda Hospital
    Advanced glycation end-product
    Glycosuria
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of May 8, 2017