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NCT03024788 Clinical Trial

Determination of the Optimum Cut-off Value of Type 2 Diabetes Diagnosis Among Chinese Population(SENSIBLE STUDY II)

Type II Diabetes Clinical Trial

Official title:
Determination of Cut-off Value of Advanced Glycation End-product and Glycosylated Haemoglobin in Type 2 Diabetes Diagnosis in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03024788
Other study ID # 2016YFC1305700d
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 11, 2017
Last updated May 3, 2017
Start date January 2017
Est. completion date December 2020

Study information
Verified date May 2017
Source Zhongda Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China

Description:

To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c level,and find the point where the prevalence of retinopathy changes most rapidly.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 6000
Est. completion date December 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- 20~70 years old;

- Volunteer to participate in this study and signed informed consent.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• syringe, fundus camera etc
Physical examination, fundus examination, blood and urine samples collection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhongda Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of retinopathy the prevalence of retinopathy in different AGEsP and HbA1c levels 3 years
Secondary incidence of retinopathy incidence of retinopathy in different AGEsP and HbA1c levels 3 years
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