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Clinical Trials/TCTR20210308001
TCTR20210308001
Completed
Not Applicable

Optical Coherence Tomography Angiography Biomarkers in Diabetic Nephropathy Patients in Thailand: A Diabetic Eye and Kidney Diseases (DEK-D) Study

Ratchadapiseksompotch Fund0 sites186 target enrollmentMarch 8, 2021
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ConditionsDiabetic mellitusDiabetic nephropathyDiabetic retinopathyMicroalbuminuriaMacroalbuminuriadiabetes mellitusdiabetic retinopathydiabetic nephropathymicroalbuminuriamacroalbuminuriaoptical coherence tomography angiographyOCTAvessel densityintercapillary area

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic mellitusDiabetic nephropathyDiabetic retinopathyMicroalbuminuriaMacroalbuminuria
Sponsor
Ratchadapiseksompotch Fund
Enrollment
186
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 8, 2021
End Date
March 21, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Ratchadapiseksompotch Fund

Eligibility Criteria

Inclusion Criteria

  • •1\.Participants aged 18\-70 years with a diagnosis of type 2 diabetes mellitus according to diagnostic criteria by the American Diabetes Association
  • •2\.History of 24\-urine albumin and creatinine testing within 3 months prior the recruitment
  • •3\.For no DN group, participants with 24\-hour urine albumin \<30 mg
  • •4\.For early DN group, participant with 24\-hour urine albumin 30\-300 mg
  • •5\.For late DN group, participants with 24\-hour urine albumin \>300 mg
  • •6\.Absence of retinal anomaly other than diabetic retinopathy

Exclusion Criteria

  • •1\.History of ocular trauma or surgery other than uncomplicated cataract surgery
  • •2\.History corneal disorders, strabismus, nystagmus, uveitis, glaucoma, optic nerve abnormalities, neurological disorders or other abnormalities affecting the visual pathway
  • •3\.History of retinal laser treatment or intravitreal anti\-vascular growth factor (anti\-VEGF) treatment
  • •4\.Presence of diabetic macular edema or tractional retinal detachment
  • •5\.Media opacities preventing reliable retinal imaging
  • •6\.Active urinary tract infection
  • •7\.Suspected of any non\-diabetic renal diseases
  • •8\.End\-stage kidney disease requiring dialysis or kidney transplantation
  • •9\.Participants who could not cooperate adequately for the OCTA examination

Outcomes

Primary Outcomes

Not specified

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