Evaluation of Innovated Screening Tools for Type 2 Diabetes Among Chinese Population(SENSIBLE STUDY I)

Type II Diabetes Mellitus Clinical Trial

Official title:

Using 2h-glycosuria Combined With Fasting Plasma Glucose , Advanced Glycation End-product Alone or in Combination With Fasting Plasma Glucose in Diabetes Screening in Chinese Natural Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03025919
• Other study ID #: 2016YFC1305700s
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2017
• Last updated: May 3, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population

Description:

Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• 20~70 year old urban and rural residents;

• Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Locations

Country	Name	City	State
China	Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the ROC curve	area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population	6 months
Secondary	sensitivity and specificity of screening	Using WHO criteria as golden standard,sensitivity and specificity of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population	6 months