Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Children and Adolescent Registry for Diabetes Study in Jiangxi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399565
Recruitment Status : Unknown
Verified January 2018 by YunFeng Shen, Second Affiliated Hospital of Nanchang University.
Recruitment status was:  Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
YunFeng Shen, Second Affiliated Hospital of Nanchang University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetes Mellitus

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : January 18, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HbA1C [ Time Frame: About 3 months after the visit ]
    HbA1c <7%

  2. blood pressure [ Time Frame: About 3 months after the visit ]
    systolic blood pressure <130mm Hg, diastolic blood pressure<80mmHg

  3. TC [ Time Frame: About 3 months after the visit ]
    TC<5.2mmol/L

  4. TG [ Time Frame: About 3 months after the visit ]
    TG<1.7mmol/L

  5. LDL-C [ Time Frame: About 3 months after the visit ]
    LDL-C<2.6mmol/L

  6. HDL-C [ Time Frame: About 3 months after the visit ]
    HDL-C>1.0mmol/L


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Second Affiliated Hospital of Nanchang University
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399565


Contacts
Layout table for location contacts
Contact: YunFeng Shen 18970819455 1023744018@qq.com
Contact: MeiHua Wu 18970819455 1023744018@qq.com

Locations
Layout table for location information
China, Jiangxi
The Second Affiliated Hospital Of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330000
Contact: Yunfeng Shen    18970819455    1023744018@qq.com   
Contact: Meihua Wu    18970819455    1023744018@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: YunFeng Shen, professor, Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT03399565    
Other Study ID Numbers: SecondNanchangU
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases