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.