To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi ProvinceNCT03363360
Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey
An observational study of To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi Province, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The study is a multicenter, sub-center contrast, cross-sectional survey.The primary objective of this study was to assess the Comprehensive Awareness and Control of blood glucose, blood pressure, and blood lipids among patients with type 2 diabetes in China Jiangxi. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi Province
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 31 Dec 2018
- How long will I take part?
- 1 Day
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 to 80 - year - old diabetic patients
Who may be able to join
- Patients aged 20 years to 80 years who were diagnosed with diabetes according to the World Health Organization criteria, at least 1 years before screening,written informed consent
Who cannot join
- Patients if they were pregnant or Other special types of diabetes, Patients with malignant tumor,participating in any other clinical studies, In phase of acute infection, trauma, such as stress state and acute phase of disease and other anomalies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.1MinDeRoad
Nanchang, Jiangxi, 341000
Shen YenFeng, professor, 18970819455, 1359112481@qq.com
About this study
The study is a multicenter, sub-center contrast, cross-sectional survey.The primary objective of this study was to assess the Comprehensive Awareness and Control of blood glucose, blood pressure, and blood lipids among patients with type 2 diabetes in China Jiangxi. An additional objective was to investigate the impact of hospital type on clinical outcomes.
Read the detailed description
Background: With the continuous improvement of living standards in the past 30 years, the lifestyle and diet of Chinese people have undergone significant changes, leading to a significant increase in the prevalence of diabetes, hypertension and lipid metabolism disorders. Prevention and control work is also increasingly valued. At present, there is no research on the awareness rates and control rates of blood glucose, blood pressure and blood lipids in diabetic patients in Jiangxi Province. During the 13th Five-Year Plan period, the country has vigorously promoted the grading system of chronic non-communicable diseases, but there is a big gap between the levels of disease management in different levels of hospitals.
Methods:The province's multi-center, sub-center control, cross-sectional survey, the number of cases planned to be included in 10000 cases. Patient Access: Within 2 years from the date of the study (December 2016), eligible patients were screened out of outpatients in the participating hospitals, and patients were reviewed and informed of the informed consent.Inclusion criteria: in line with the WHO1999 diabetes diagnostic criteria; age 20-80 years; duration of 1 year or more; signed informed consent. Exclusion criteria: at the same time using other experimental drugs or in other clinical trials; gestational diabetes, other special types of diabetes; in acute infection, trauma and other stress conditions and the acute phase of the disease and other anomalies; patients with malignant tumors.
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c <7%
Measured: The first 30 days or seven days after the visit
TC
TC<5.2mmol/L
Measured: The first 30 days or seven days after the visit
TG
TG<1.7mmol/L
Measured: The first 30 days or seven days after the visit
LDL-C
LDL-C<3.3mmol/L
Measured: The first 30 days or seven days after the visit
HDL-C
HDL-C>1.0mmol/L
Measured: The first 30 days or seven days after the visit
Secondary outcomes (1)
blood pressure
systolic blood pressure <130 mm Hg, diastolic blood pressure <80 mm Hg
Measured: On the day of the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Dec 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 To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi ProvinceStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Day
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
- NCT03363360
- Sponsor's protocol ID
- DM20161201
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the form of a paper published based on the results of the study
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey
- ClinicalTrials.gov ID
- NCT03363360
- Acronym / sponsor ID
- DM20161201
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 6 Dec 2017 (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.
The study is a multicenter, sub-center contrast, cross-sectional survey.The primary objective of this study was to assess the Comprehensive Awareness and Control of blood glucose, blood pressure, and blood lipids among patients with type 2 diabetes in China Jiangxi. An additional objective was to investigate the impact of hospital type on clinical outcomes.
Detailed description
Background: With the continuous improvement of living standards in the past 30 years, the lifestyle and diet of Chinese people have undergone significant changes, leading to a significant increase in the prevalence of diabetes, hypertension and lipid metabolism disorders. Prevention and control work is also increasingly valued. At present, there is no research on the awareness rates and control rates of blood glucose, blood pressure and blood lipids in diabetic patients in Jiangxi Province. During the 13th Five-Year Plan period, the country has vigorously promoted the grading system of chronic non-communicable diseases, but there is a big gap between the levels of disease management in different levels of hospitals.
Methods:The province's multi-center, sub-center control, cross-sectional survey, the number of cases planned to be included in 10000 cases. Patient Access: Within 2 years from the date of the study (December 2016), eligible patients were screened out of outpatients in the participating hospitals, and patients were reviewed and informed of the informed consent.Inclusion criteria: in line with the WHO1999 diabetes diagnostic criteria; age 20-80 years; duration of 1 year or more; signed informed consent. Exclusion criteria: at the same time using other experimental drugs or in other clinical trials; gestational diabetes, other special types of diabetes; in acute infection, trauma and other stress conditions and the acute phase of the disease and other anomalies; patients with malignant tumors.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 to 80 - year - old diabetic patients
Key inclusion criteria (1 listed)
- Patients aged 20 years to 80 years who were diagnosed with diabetes according to the World Health Organization criteria, at least 1 years before screening,written informed consent
Key exclusion criteria (1 listed)
- Patients if they were pregnant or Other special types of diabetes, Patients with malignant tumor,participating in any other clinical studies, In phase of acute infection, trauma, such as stress state and acute phase of disease and other anomalies
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: The first 30 days or seven days after the visit
HbA1c <7%
TC
Time frame: The first 30 days or seven days after the visit
TC<5.2mmol/L
TG
Time frame: The first 30 days or seven days after the visit
TG<1.7mmol/L
LDL-C
Time frame: The first 30 days or seven days after the visit
LDL-C<3.3mmol/L
HDL-C
Time frame: The first 30 days or seven days after the visit
HDL-C>1.0mmol/L
1 secondary outcome
blood pressure
Time frame: On the day of the visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: Yes. In the form of a paper published based on the results of the study
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 To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi Province, 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 1 inclusion and 1 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 6 Dec 2017. 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 Shen YunFeng, professor (18970819455, 1359112481@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: The first 30 days or seven days after the visit). The study lists 5 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 6 Dec 2017.