Viewing Study NCT01810822



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Study NCT ID: NCT01810822
Status: COMPLETED
Last Update Posted: 2013-03-14
First Post: 2013-03-11

Brief Title: Sex-specific Association With Kidney Disease
Sponsor: University of Sao Paulo General Hospital
Organization: University of Sao Paulo General Hospital

Study Overview

Official Title: Sex-specific Associations of Variants in the Regulatory Regions of NADPH Oxidase-2 CYBB and Gluthatione Peroxidase 4 GPX4 Genes With Kidney Disease in Type 1 Diabetes
Status: COMPLETED
Status Verified Date: 2013-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Oxidative stress is involved in the pathophysiology of diabetic nephropathy The superoxide-generating nicotinamide adenine dinucleotide phosphate-oxidase 2 NOX2 encoded by the CYBB gene and the antioxidant enzyme glutathione peroxidase 4 GPX4 play opposing roles in the balance of cellular redox status In the present study we investigated associations of single nucleotide polymorphisms SNPs in the regulatory regions of CYBB and GPX4 with kidney disease in patients with type 1 diabetes
Detailed Description: In the present study three cohorts of type 1 diabetic patients one Brazilian and two FrenchBelgium cohorts were studied for the association with diabetic nephropathy DN with a total of 1396 patients The patients were classified according to the urinary albumin-to-creatinine ratio ACR or urinary albumin excretion rate UAER in absence of nephropathy defined as ACR 30 mgg or UAER 20 µgmin or 20 mgL and plasma creatinine 17 mgdL incipient nephropathy defined as persistent microalbuminuria ACR 30 - 300 mgg of creatinine or UAER 20 - 200 µgmin or 20 - 200 mgL and plasma creatinine 17 mgdL established diabetic nephropathy defined as past or present macroalbuminuria ACR 300 mgg of creatinine or UAER 200 µgmin or 200 mgL and plasma creatinine 17 mgdL advanced diabetic nephropathy defined as past or present macroalbuminuria plasma creatinine 17 mgdL and any renal replacement therapy Genotyping of polymorphisms was performed by Real Time PCR using fluorescent-labelled probes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None