Diabetes MellitusNCT03399565
Children and Adolescent Registry for Diabetes Study in Jiangxi
An observational study of Diabetes Mellitus, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 day to 30 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The Second Affiliated Hospital of Nanchang University
Who may be able to join
- Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria;
- Gender is not limited.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000
Yunfeng Shen, 18970819455, 1023744018@qq.com
Meihua Wu, 18970819455, 1023744018@qq.com
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
HbA1c <7%
Measured: About 3 months after the visit
blood pressure
systolic blood pressure <130mm Hg, diastolic blood pressure<80mmHg
Measured: About 3 months after the visit
TC
TC<5.2mmol/L
Measured: About 3 months after the visit
TG
TG<1.7mmol/L
Measured: About 3 months after the visit
LDL-C
LDL-C<2.6mmol/L
Measured: About 3 months after the visit
HDL-C
HDL-C>1.0mmol/L
Measured: About 3 months after the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start18 Jan 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YunFeng Shen, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399565
- Sponsor's protocol ID
- SecondNanchangU
- Status last verified
- Jan 2018
- First submitted
- 4 Dec 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children and Adolescent Registry for Diabetes Study in Jiangxi
- ClinicalTrials.gov ID
- NCT03399565
- Acronym / sponsor ID
- SecondNanchangU
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The Second Affiliated Hospital of Nanchang University
Key inclusion criteria (2 listed)
- Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria;
- Gender is not limited.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1C
Time frame: About 3 months after the visit
HbA1c <7%
blood pressure
Time frame: About 3 months after the visit
systolic blood pressure <130mm Hg, diastolic blood pressure<80mmHg
TC
Time frame: About 3 months after the visit
TC<5.2mmol/L
TG
Time frame: About 3 months after the visit
TG<1.7mmol/L
LDL-C
Time frame: About 3 months after the visit
LDL-C<2.6mmol/L
HDL-C
Time frame: About 3 months after the visit
HDL-C>1.0mmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YunFeng Shen (18970819455, 1023744018@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: About 3 months after the visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.