SLC2A1 Variants and Diabetic Nephropathy

NCT ID: NCT01768611

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

449 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nephropathy.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Withou Diabetic Nephropathy

Patients who have persistent normoalbuminuria (\<30 mg/g creatinine or \<20 μg/min).

No interventions assigned to this group

Incipient Nephropathy

Patients who have persistent microalbuminuria (30-300 mg/g creatinine or 20-200 μg/min).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria L Côrrea-Giannela, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínicas/Faculdade de Medicina da USP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMUSP-LIM25-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.