SLC2A1 Variants and Diabetic Nephropathy

NCT01768611 | Completed DMC

• 1 other identifier: FMUSP-LIM25-001
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy.

Outcome Measures

Primary Outcomes (1)

• Plasmatic Creatinine

  Two years

Study Arms (3)

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.

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Overt 10 years of Diabetes Mellitus

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Faculdade de Medicina da USP

São Paulo, São Paulo, 01246-000, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Maria L Côrrea-Giannela, Doctor

  Hospital Clínicas/Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: January 15, 2013
• Study Start: October 1, 2004
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

BR (1)