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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Kidney Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on June 18, 2013