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Children and Adolescent Registry for Diabetes Study in Jiangxi

Sponsor
Second Affiliated Hospital of Nanchang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03399565
Collaborator
(none)
300
Enrollment
1
Location
35.4
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background:With the development of economy and the improvement of people's living standards, the incidence of childhood diabetes is rapidly increasing.The multicenter, prospective,retrospectively in children and adolescents registry for diabetes in jiangxi aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

    Methods:The province's multi-center, prospective态retrospective study, the number of cases planned to be included in 300 cases.The inclusion criteria:A diagnosis of diabetes;reported for diabetes by parents and patients or by doctors and medical records to prove all of the patients;0-30 years old, gender not limited;voluntary participation and sign a consent form.Exclusion criteria

    :At the same time, other test drugs or are other clinical trials;Due to other reasons, the researchers think that the person doesn't fit into the group;Diabetes during pregnancy;Besides diabetes diagnosis of tumor, cardiovascular disease and other interfere with the results of the study of disease.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Children and Adolescent Registry for Diabetes Study in Jiangxi
    Actual Study Start Date :
    Jan 18, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2018
    Anticipated Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. HbA1C [About 3 months after the visit]

      HbA1c <7%

    2. blood pressure [About 3 months after the visit]

      systolic blood pressure <130mm Hg, diastolic blood pressure<80mmHg

    3. TC [About 3 months after the visit]

      TC<5.2mmol/L

    4. TG [About 3 months after the visit]

      TG<1.7mmol/L

    5. LDL-C [About 3 months after the visit]

      LDL-C<2.6mmol/L

    6. HDL-C [About 3 months after the visit]

      HDL-C>1.0mmol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria;

    • Gender is not limited.

    Exclusion Criteria:

    • Gestational diabetes mellitus;

    • Patients with malignant tumor,cardiovascular disease and other interference with the results of the study of the disease.

    • Patients are participating in any other clinical studies;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Affiliated Hospital Of Nanchang University Nanchang Jiangxi China 330000

    Sponsors and Collaborators

    • Second Affiliated Hospital of Nanchang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    YunFeng Shen, professor, Second Affiliated Hospital of Nanchang University
    ClinicalTrials.gov Identifier:
    NCT03399565
    Other Study ID Numbers:
    • SecondNanchangU
    First Posted:
    Jan 16, 2018
    Last Update Posted:
    Jan 16, 2018
    Last Verified:
    Jan 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of Jan 16, 2018