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Sex-specific Association With Kidney Disease

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ClinicalTrials.gov Identifier: NCT01810822
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease
Diabetic Nephropathy

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.

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Study Type : Observational
Actual Enrollment : 1396 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.
Study Start Date : May 1994
Actual Primary Completion Date : May 1994
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Genesis French-Belgium Study
Cross-sectional, multi-center, binational (Belgian and France) study designed to evaluate the genetic components of diabetic nephropathy. It is a cohort with 501 patients, including 279 individuals (55.7%) with diagnosis of diabetic nephropathy.
GENEDIAB
Cross-sectional, multi-center, binational (Belgian and France) study designed to evaluate the genetic components of diabetic nephropathy. It is a cohort with 444 patients, including 310 individuals (69.8%) with diagnosis of diabetic nephropathy.
Brazilian cohort
The cohort comprised 451 patients with type 1 diabetes for more than 10 years (56% women; aged 36 ± 11 years, mean ± SD) recruited in diabetes/endocrinology departments of three university hospitals in the cities of São Paulo (SP), Campinas (SP) and Porto Alegre (RS), Brazil.



Primary Outcome Measures :
  1. Albumin to Creatinine Ratio [ Time Frame: Two Years ]

Biospecimen Retention:   Samples With DNA
Whole Blood


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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Three cohorts pf type 1 diabetic patients were used for the present study. The first one is a Brazilian cohort with 451 patients recruited in diabetes/endocrinology departments of three university hospitals in the cities of São Paulo (SP), Campinas (SP) and Porto Alegre (RS), Brazil between October 2004 and October 2012. The second one is a French/Belgium cohort with 501 patients recruited from both countries between November 1998 to December 2000. The third cohort is a French/Belgium cohort with 444 patients recruited from both countries between May 1994 to April 1995.
Criteria

Inclusion Criteria:

  • Overt 10 years of Diabetes Mellitus (Brazilian cohort)
  • Diagnostic of diabetes before the age of 35 years, with initial ketosis and requirement for permanent insulin treatment within 1 year of diagnosis and past or present diagnosis of diabetic retinopathy. (Genesis cohort).
  • Diagnostic of diabetes before the age of 35 years and past or present diagnosis of severe diabetic retinopathy. (GENEDIAB cohort).

Exclusion Criteria:

  • Patients presenting autoimmune diseases, HIV or HCV infections (Brazilian cohort)
  • Patients with glomerular filtration rate < 60 mL min−1 1.73 m2 without diabetic retinopathy (Brazilian cohort)
  • Terminal cancer and personal disability (GENEDIAB cohort).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810822


Locations
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Brazil
Faculty of Medicine from University of São Paulo
São Paulo, SP, Brazil, 01246-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Maria L Côrrea-Giannela, Doctor Clinical Hospital/Faculty of Medicine from University of São Paulo
Study Director: Gilberto Velho, Doctor INSERM U695

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01810822     History of Changes
Other Study ID Numbers: FMUSP-LIM25-0002
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by University of Sao Paulo General Hospital:
oxidative stress
genetic susceptibility
GPX4
NOX2
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases