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Comprehensive Awareness and Control in Diabetes Patients in China Jiangxi: A Cross-Sectional Survey

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ClinicalTrials.gov Identifier: NCT03363360
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):
YunFeng Shen, Second Affiliated Hospital of Nanchang University

Brief 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. An additional objective was to investigate the impact of hospital type on clinical outcomes.

Condition or disease
To Assess the Level of Control of Blood Glucose, Blood Pressure, and Blood Lipids Among Patients With Type 2 Diabetes in Jiangxi Province

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c [ Time Frame: The first 30 days or seven days after the visit ]
    HbA1c <7%

  2. TC [ Time Frame: The first 30 days or seven days after the visit ]

  3. TG [ Time Frame: The first 30 days or seven days after the visit ]

  4. LDL-C [ Time Frame: The first 30 days or seven days after the visit ]

  5. HDL-C [ Time Frame: The first 30 days or seven days after the visit ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: On the day of the visit ]
    systolic blood pressure <130 mm Hg, diastolic blood pressure <80 mm Hg

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
20 to 80 - year - old diabetic patients

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

Information from the National Library of Medicine

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   
Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University

Responsible Party: YunFeng Shen, professor, Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT03363360     History of Changes
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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases