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SLC2A1 Variants and Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT01768611
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Cells damaged by hyperglycemia are unable to downregulate glucose entrance in presence of high extracellular glucose resulting in intracellular activation of deleterious biochemical pathways. Expression of GLUT-1, the major glucose transporter in mesangial cells, is increased and participates in the induction of diabetic nephropathy. Variants in the gene encoding GLUT-1 (SLC2A1) have been associated to this diabetic complication. The aim of this study was to test whether polymorphisms in SLC2A1 confer susceptibility to diabetic nephropathy in Brazilian type 1 diabetes patients.

Condition or disease
Diabetic Nephropathy.

Detailed Description:
In this study, 449 patients, included between October 2004 and October 2012, were sorted into three groups according to diabetic nephropathy stages: without (persistent normoalbuminuria, n=248), incipient (microalbuminuria, n=82) and overt diabetic nephropathy (macroalbuminuria or proteinuria or renal replacement therapy, n=119). Measurements of urinary albumin-to-creatinine ratio (ACR) or urinary albumin excretion rate (UAER) were used to define DN: patients with persistent normoalbuminuria (<30 mg/g creatinine or <20 μg/min) were classified as without DN (n=248); patients presenting persistent microalbuminuria (30-300 mg/g creatinine or 20-200 μg/min) were classified as having incipient DN (n=82); and patients presenting persistent macroalbuminuria (>300 mg/g creatinine or >200 µg/min), proteinuria (>500 mg/24 h) or renal replacement therapy were classified as having overt DN (n=119). Genotyping of polymorphisms was performed by Real Time PCR using fluorescent -labelled probes.

Study Design

Study Type : Observational
Actual Enrollment : 449 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Association of Single Nucleotide Polymorphisms in the Gene Coding GLUT-1 and Diabetic Nephropathy in Brazilian Patients With Type 1 Diabetes Mellitus
Study Start Date : October 2004
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Withou Diabetic Nephropathy
Patients who have persistent normoalbuminuria (<30 mg/g creatinine or <20 μg/min).
Incipient Nephropathy
Patients who have persistent microalbuminuria (30-300 mg/g creatinine or 20-200 μg/min).
Overt Diabetic Nephropathy
Patients who have persistent macroalbuminuria (>300 mg/g creatinine or >200 µg/min), proteinuria (>500 mg/24 h) or renal replacement therapy.


Outcome Measures

Primary Outcome Measures :
  1. Plasmatic Creatinine [ Time Frame: Two years ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Eligibility Criteria

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
449 patients with type 1 diabetes (56.4% female, mean age 36.0±11.0 years) were included between October 2004 and October 2012. Inclusion criterion was type 1 diabetes duration ≥10 years. The patients presented a mixed ethnic background (European Caucasian, African, Amerindian and Asian of several different countries of origin), which reflects the Brazilian population.
Criteria

Inclusion Criteria:

  • Overt 10 years of Diabetes Mellitus

Exclusion Criteria:

  • Patients presenting autoimmune diseases, HIV or HCV infections
  • Patients with glomerular filtration rate < 60 mL min−1 1.73 m2 without diabetic retinopathy
Contacts and Locations

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): NCT01768611


Locations
Brazil
Faculdade de Medicina da USP
São Paulo, SP, Brazil, 01246-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Maria L Côrrea-Giannela, Doctor Hospital Clínicas/Faculdade de Medicina da USP
More Information

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01768611     History of Changes
Other Study ID Numbers: FMUSP-LIM25-001
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases