Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey
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| ClinicalTrials.gov Identifier: NCT03363360 |
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Recruitment Status : Unknown
Verified November 2017 by YunFeng Shen, Second Affiliated Hospital of Nanchang University.
Recruitment status was: Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
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| Condition or disease |
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| To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi Province |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey |
| Actual Study Start Date : | December 1, 2016 |
| Estimated Primary Completion Date : | December 31, 2018 |
| Estimated Study Completion Date : | December 31, 2018 |
- 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
- blood pressure [ Time Frame: On the day of the visit ]systolic blood pressure <130 mm Hg, diastolic blood pressure <80 mm Hg
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| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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): NCT03363360
| Contact: Shen YunFeng, professor | 18970819455 | 1359112481@qq.com | |
| Contact: Wang Jun | 15797727918 | 1359112481@qq.com |
| China, Jiangxi | |
| No.1MinDeRoad | Recruiting |
| Nanchang, Jiangxi, China, 341000 | |
| Contact: Shen YenFeng, professor 18970819455 1359112481@qq.com | |
| Responsible Party: | YunFeng Shen, professor, Second Affiliated Hospital of Nanchang University |
| ClinicalTrials.gov Identifier: | NCT03363360 |
| Other Study ID Numbers: |
DM20161201 |
| First Posted: | December 6, 2017 Key Record Dates |
| Last Update Posted: | December 6, 2017 |
| Last Verified: | November 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | In the form of a paper published based on the results of the study |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Within 1 years of completion of the study |
| Access Criteria: | Researchers who need the results of this study |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |