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Shanghai Beixinjing Diabetic Eyes Study (SBDES)

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ClinicalTrials.gov Identifier: NCT03571217
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

Study Description
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Brief Summary:
In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. The well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (CVA) impairment, mainly because of its unknown pathogenesis. In our previous population-based study, the prevalence rate of early CVA impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. Of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early CVA impairment is related to diabetic choroidopathy (DC). Recent research shows that the decreased macular choriocapillaris vessel density (MCVD) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (SFCT) decreased significantly in the early CVA impairment patients. However, up til now, there was no epidemiology report on early CVA impairment in Chinese diabetes population. In the present study, we plan to conduct a 10-year perspective cohort observation of 2217 Chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. The results will facilitate discriminating high risk groups of early CVA impairment in diabetic patients. In the same time, a quantitative relationship between SFCT change, MCVD change and CVA change will be established. This study will demonstrate the role of DC in the occurrence of preclinical CVA impairment, and provide important theoretic evidence of blocking agents which target on DC.

Condition or disease
Diabetic Retinopathy Visual Impairment Diabetic Maculopathy

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Cohort Study of Incidence and Disk Factors of Diabetic Retinopathy and Visual Impairment in Adults With Type 2 Diabetes
Actual Study Start Date : October 1, 2014
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Diabetic retinopathy cohort
Mild visual impairment cohort


Outcome Measures
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Primary Outcome Measures :
  1. Diabetic retinopathy [ Time Frame: December 31，2024 ]
    The DR grades are according to the well-accepted ''International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale''

  2. mild visual impairment [ Time Frame: December 31，2024 ]
    Mild visual impairment was present if BCVA was < 20/25 but ≥ 20/63.

  3. macular choriocapillaris vessel density(MCVD) [ Time Frame: December 31，2024 ]
    macular choriocapillaris vessel density

  4. glycosylated hemoglobin [ Time Frame: December 31，2024 ]
    This test measures the average blood sugar control for the previous three months or so.

  5. retinal thickness (RT) [ Time Frame: December 31，2024 ]
    Retinal thickness was defined as the distance from the internal limiting membrane to the interface of the photoreceptor outer segments and retinal pigment epithelium.

  6. choroidal thickness (CT) [ Time Frame: December 31，2024 ]
    Choroidal thickness was measured from the outer border of the RPE to the inner border of the choroidoscleral interface.


Biospecimen Retention:   Samples Without DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Type 2 diabetes mellitus. Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.
Criteria

Inclusion Criteria:

  • ≥18 years old;
  • Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.

Exclusion Criteria:

  • None;
Contacts and Locations
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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): NCT03571217


Contacts
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Contact: Haidong Zou, MD, PhD 8613311986528 zouhaidong@263.net

Locations
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China, Shanghai
Shanghai Eye Disease Prevention & Treatment Center Recruiting
Shanghai, Shanghai, China, 200040
Contact: Haidong Zou, Ph.D    8613311986528    zouhaidong@263.net   
Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Investigators
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Study Chair: Haidong Zou, MD, PhD Shanghai Eye Disease Prevention & Treatment Center
More Information
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Additional Information:

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Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03571217    
Other Study ID Numbers: YFZX2018003
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Eye Disease Prevention and Treatment Center:
Type 2 diabetes mellitus
diabetic retinopathy
visual impairment
diabetic choroidopathy
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Retinal Degeneration