- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03571217
Shanghai Beixinjing Diabetic Eyes Study (SBDES)
18. juni 2018 opdateret af: Shanghai Eye Disease Prevention and Treatment Center
The Cohort Study of Incidence and Disk Factors of Diabetic Retinopathy and Visual Impairment in Adults With Type 2 Diabetes
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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
2500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Haidong Zou, MD, PhD
- Telefonnummer: 8613311986528
- E-mail: zouhaidong@263.net
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200040
- Rekruttering
- Shanghai Eye Disease Prevention & Treatment Center
-
Kontakt:
- Haidong Zou, Ph.D
- Telefonnummer: 8613311986528
- E-mail: zouhaidong@263.net
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Diabetic retinopathy cohort
|
|
Mild visual impairment cohort
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diabetic retinopathy
Tidsramme: December 31,2024
|
The DR grades are according to the well-accepted ''International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale''
|
December 31,2024
|
|
mild visual impairment
Tidsramme: December 31,2024
|
Mild visual impairment was present if BCVA was < 20/25 but ≥ 20/63.
|
December 31,2024
|
|
macular choriocapillaris vessel density(MCVD)
Tidsramme: December 31,2024
|
macular choriocapillaris vessel density
|
December 31,2024
|
|
glycosylated hemoglobin
Tidsramme: December 31,2024
|
This test measures the average blood sugar control for the previous three months or so.
|
December 31,2024
|
|
retinal thickness (RT)
Tidsramme: 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.
|
December 31,2024
|
|
choroidal thickness (CT)
Tidsramme: December 31,2024
|
Choroidal thickness was measured from the outer border of the RPE to the inner border of the choroidoscleral interface.
|
December 31,2024
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Haidong Zou, MD, PhD, Shanghai Eye Disease Prevention & Treatment Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2014
Primær færdiggørelse (Forventet)
31. december 2024
Studieafslutning (Forventet)
31. december 2024
Datoer for studieregistrering
Først indsendt
18. juni 2018
Først indsendt, der opfyldte QC-kriterier
18. juni 2018
Først opslået (Faktiske)
27. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i nervesystemet
- Øjensygdomme
- Neurologiske manifestationer
- Sygdomme i det endokrine system
- Diabetiske angiopatier
- Diabetes komplikationer
- Diabetes mellitus
- Nethindedegeneration
- Sensationsforstyrrelser
- Makuladegeneration
- Nethindesygdomme
- Diabetisk retinopati
- Syn, lav
- Synsforstyrrelser
Andre undersøgelses-id-numre
- YFZX2018003
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