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

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Shen YunFeng, professor; Phone Number: 18970819455; Email: 1359112481@qq.com
• Study Contact Backup: Name: Wang Jun; Phone Number: 15797727918; Email: 1359112481@qq.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 341000
      • Recruiting
      • No.1MinDeRoad
      • Contact: Shen YenFeng, professor; Phone Number: 18970819455; Email: 1359112481@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

20 to 80 - year - old diabetic patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c <7%	The first 30 days or seven days after the visit
TC	TC<5.2mmol/L	The first 30 days or seven days after the visit
TG	TG<1.7mmol/L	The first 30 days or seven days after the visit
LDL-C	LDL-C<3.3mmol/L	The first 30 days or seven days after the visit
HDL-C	HDL-C>1.0mmol/L	The first 30 days or seven days after the visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	systolic blood pressure <130 mm Hg, diastolic blood pressure <80 mm Hg	On the day of the visit

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: DM20161201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In the form of a paper published based on the results of the study
• IPD Sharing Time Frame: Within 1 years of completion of the study
• IPD Sharing Access Criteria: Researchers who need the results of this study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No