NCT01810822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1994

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1994

Completed
18.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

Same day

First QC Date

March 11, 2013

Last Update Submit

March 13, 2013

Conditions

Diabetic Nephropathy

Keywords

oxidative stressgenetic susceptibilityGPX4NOX2

Outcome Measures

Primary Outcomes (1)

  • Albumin to Creatinine Ratio

    Two Years

Study Arms (3)

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.

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine from University of São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Diabetic NephropathiesGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria L Côrrea-Giannela, Doctor

    Clinical Hospital/Faculty of Medicine from University of São Paulo

    STUDY DIRECTOR

  • Gilberto Velho, Doctor

    INSERM U695

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 14, 2013

Study Start

May 1, 1994

Primary Completion

May 1, 1994

Study Completion

October 1, 2012

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

BR(1)