Children and Adolescent Registry for Diabetes Study in Jiangxi

Diabetes Mellitus Clinical Trial

Official title:

Children and Adolescent Registry for Diabetes Study in Jiangxi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399565
• Other study ID #: SecondNanchangU
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2017
• Last updated: January 8, 2018
• Start date: January 18, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: Second Affiliated Hospital of Nanchang University
• Contact: YunFeng Shen
• Phone: 18970819455
• Email: 1023744018[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

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