- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03399565
Children and Adolescent Registry for Diabetes Study in Jiangxi
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yunfeng Shen
- Phone Number: 18970819455
- Email: 1023744018@qq.com
Study Contact Backup
- Name: Meihua Wu
- Phone Number: 18970819455
- Email: 1023744018@qq.com
Study Locations
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-
Jiangxi
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Nanchang, Jiangxi, China, 330000
- Recruiting
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Yunfeng Shen
- Phone Number: 18970819455
- Email: 1023744018@qq.com
-
Contact:
- Meihua Wu
- Phone Number: 18970819455
- Email: 1023744018@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SecondNanchangU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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