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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00600236
Other study ID # APEC-0018
Secondary ID
Status Completed
Phase Phase 3
First received June 30, 2006
Last updated January 23, 2008
Start date September 2004
Est. completion date January 2008

Study information

Verified date January 2008
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority Mexico: Secretaria de Salud
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
blood sample


Locations

Country Name City State
Mexico Asociación para Evitar la Ceguera en México, Hospital "Luis Sanchez Bulnes" Mexico City Mexico DF

Sponsors (2)

Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México Instituto Nacional de Referencia Epidemiológica (INdRE)

Country where clinical trial is conducted

Mexico, 

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