Clinical Trials Directory

Trials / Completed

CompletedNCT01810822

Sex-specific Association With Kidney Disease

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
Phase
Study type
Observational
Enrollment
1,396 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
11 Years
Healthy volunteers
Not accepted

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 French/Belgium 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 mg/g or UAER \< 20 µg/min or \< 20 mg/L and plasma creatinine \<1.7 mg/dL; incipient nephropathy, defined as persistent microalbuminuria (ACR 30 - 300 mg/g of creatinine or UAER 20 - 200 µg/min or 20 - 200 mg/L) and plasma creatinine \<1.7 mg/dL; established diabetic nephropathy, defined as past or present macroalbuminuria (ACR \>300 mg/g of creatinine or UAER \>200 µg/min or \> 200 mg/L) and plasma creatinine \<1.7 mg/dL; advanced diabetic nephropathy, defined as past or present macroalbuminuria, plasma creatinine \>1.7 mg/dL and any renal replacement therapy. Genotyping of polymorphisms was performed by Real Time PCR using fluorescent-labelled probes.

Conditions

Timeline

Start date
1994-05-01
Primary completion
1994-05-01
Completion
2012-10-01
First posted
2013-03-14
Last updated
2013-03-14

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01810822. Inclusion in this directory is not an endorsement.