Back to resultsHLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
Primary Purpose
Diabetes Mellitus Type 2, Proliferative Diabetic Retinopathy
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus Type 2 focused on measuring Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy, Diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
Eligibility Criteria
Inclusion Criteria:
- Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy
- Diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy
Exclusion Criteria:
- Systemic hipertension
- Cardic disease
- Lupus
- Any kind of artritis
- Allergies
- Optic Neuritis
- VKH
- Cancer
- Inmunological diseases
Sites / Locations
- Asociación para Evitar la Ceguera en México, Hospital "Luis Sanchez Bulnes"
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00600236
First Posted
June 30, 2006
Last Updated
January 23, 2008
Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Instituto Nacional de Referencia Epidemiológica (INdRE)
1. Study Identification
Unique Protocol Identification Number
NCT00600236
Brief Title
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
Official Title
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Instituto Nacional de Referencia Epidemiológica (INdRE)
4. Oversight
5. Study Description
Brief Summary
One of the first causes of irreversible blindness in mexican population is diabetic retinopathy which is clearly diferent between patients the time of evolution and development of retinopathy and complications. The aim of this study is to explore the inmunogenetic profile and the influence of HLA in this variations of the sickness to predict the severity of diabetic complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Proliferative Diabetic Retinopathy
Keywords
Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy, Diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
blood sample
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy
Diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy
Exclusion Criteria:
Systemic hipertension
Cardic disease
Lupus
Any kind of artritis
Allergies
Optic Neuritis
VKH
Cancer
Inmunological diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación para Evitar la Ceguera en México, Hospital "Luis Sanchez Bulnes"
City
Mexico City
State/Province
Mexico DF
ZIP/Postal Code
04030
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
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