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SLC2A1 Variants and Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01768611
First received: December 17, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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
Diabetic Nephropathy.

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Plasmatic Creatinine [ Time Frame: Two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole Blood


Enrollment: 449
Study Start Date: October 2004
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01768611     History of Changes
Other Study ID Numbers: FMUSP-LIM25-001
Study First Received: December 17, 2012
Last Updated: January 15, 2013
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on November 25, 2014