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CompletedNCT01768611Updated Jan 16, 2013

SLC2A1 Variants and Diabetic Nephropathy

An observational study in Diabetic Nephropathy., sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 11 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by University of Sao Paulo General Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
449
Ages
11 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Diabetic Nephropathy.
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 449 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years and older
Sexes eligible
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.

Inclusion criteria

  • Overt 10 years of Diabetes Mellitus

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
449 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Plasmatic Creatinine

    Time frame: Two years

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Study locations

1 site
  • Faculdade de Medicina da USP
    São Paulo, SP 01246-000, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01768611
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Sponsor
First posted
Jan 15, 2013
Start date
Oct 2004
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Jan 16, 2013

Study contacts

Maria L Côrrea-Giannela, Doctor
principal investigator · Hospital Clínicas/Faculdade de Medicina da USP

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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