- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768611
SLC2A1 Variants and Diabetic Nephropathy
January 15, 2013 updated by: University of Sao Paulo General Hospital
Association of Single Nucleotide Polymorphisms in the Gene Coding GLUT-1 and Diabetic Nephropathy in Brazilian Patients With Type 1 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
449
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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SP
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São Paulo, SP, Brazil, 01246-000
- FACULDADE DE MEDICINA DA USP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasmatic Creatinine
Time Frame: Two years
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria L Côrrea-Giannela, Doctor, Hospital Clínicas/Faculdade de Medicina da USP
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 17, 2012
First Submitted That Met QC Criteria
January 11, 2013
First Posted (Estimate)
January 15, 2013
Study Record Updates
Last Update Posted (Estimate)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMUSP-LIM25-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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