Children and Adolescent Registry for Diabetes Study in Jiangxi

January 8, 2018 updated by: YunFeng Shen, Second Affiliated Hospital of Nanchang University
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.

Study Overview

Status

Unknown

Conditions

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、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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Second Affiliated Hospital of Nanchang University

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: About 3 months after the visit
HbA1c <7%
About 3 months after the visit
blood pressure
Time Frame: About 3 months after the visit
systolic blood pressure <130mm Hg, diastolic blood pressure<80mmHg
About 3 months after the visit
TC
Time Frame: About 3 months after the visit
TC<5.2mmol/L
About 3 months after the visit
TG
Time Frame: About 3 months after the visit
TG<1.7mmol/L
About 3 months after the visit
LDL-C
Time Frame: About 3 months after the visit
LDL-C<2.6mmol/L
About 3 months after the visit
HDL-C
Time Frame: About 3 months after the visit
HDL-C>1.0mmol/L
About 3 months after the visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2016

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SecondNanchangU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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