Clinical trial NCT01768611: SLC2A1 Variants and Diabetic Nephropathy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Nephropathy.
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 449
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
measure: Plasmatic Creatinine
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da USP
state: SP
Study officials:
affiliation: Hospital Clínicas/Faculdade de Medicina da USP
name: Maria L Côrrea-Giannela, Doctor
role: PRINCIPAL_INVESTIGATOR
References: