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

• Sponsor: Zhongda Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03024788
• Collaborator: (none)
• Enrollment: 6,000
• Duration (Months): 47

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Device: syringe, fundus camera etc

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 6000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Determination of Cut-off Value of Advanced Glycation End-product and Glycosylated Haemoglobin in Type 2 Diabetes Diagnosis in China
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2020
• Study Completion Date: Dec 1, 2020

Outcome Measures

Primary Outcome Measures

1. prevalence of retinopathy [3 years]

   the prevalence of retinopathy in different AGEsP and HbA1c levels

Secondary Outcome Measures

1. incidence of retinopathy [3 years]

   incidence of retinopathy in different AGEsP and HbA1c levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 20~70 years old;

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

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhongda Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zilin Sun, director physician, Zhongda Hospital
• ClinicalTrials.gov Identifier: NCT03024788
• Other Study ID Numbers: 2016YFC1305700d
• First Posted: Jan 19, 2017
• Last Update Posted: May 8, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Zilin Sun, director physician, Zhongda Hospital: Glycosylated haemoglobin; advanced glycation end products
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 8, 2017