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Study on Tear Proteins in Diabetic Retinopathy of Type 2 Diabetics

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ClinicalTrials.gov Identifier: NCT00698698
Recruitment Status : Unknown
Verified January 2009 by Dow University of Health Sciences.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2008
Last Update Posted : February 2, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Diabetes mellitus is becoming a global epidemic. There is a need to devise a non invasive method for detection of diabetes and its related complication. Tear proteins are easy to collect causing no harm to a patient and different studies indicate that tear proteins of diabetic patients are significantly different from non diabetic population. This difference in the composition of tear proteins become more pronounced with advancement of diabetic retinopathy.

Condition or disease
Diabetes Mellitus

Detailed Description:

Diabetes mellitus causes a significant alteration in tear proteins. If we analyze tear proteins by means of electrophoresis, HPLC, and mass spectroscopy.

We can find different type of tear proteins in different grades of diabetic retinopathy these biomarkers can help in mass screening , diagnosis and management of diabetic population.


Study Design

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Tear Proteins and Diabetic Retinopathy
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Non diabetic
Normal age and sex matched population
Grade 1
Diabetic population with no retinopathy or Mild non proliferative diabetic retinopathy
Grade 2
Moderate non proliferative diabetic retinopathy
Grade 3
Severe non proliferative diabetic retinopathy
Grade 4
Proliferative diabetic retinopathy and advanced diabetic eye disease


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
diabetic population
Criteria

Inclusion Criteria:

  • diabetic patients with type 2 diabetes
  • age above 30
  • willing to participate

Exclusion Criteria:

  • ocular surface disorders.
  • collagen vascular diseases
  • Limbal hyperemia
  • previous ocular surgery
  • creatinine level above 1.0
  • liver diseases
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698698


Locations
Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 75500
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
Principal Investigator: Dr. Jamshed Ahmed, FCPS Dow University of Health Sciences Pakistan
More Information

Responsible Party: Dr.Jamshed Ahmed Assistant Professor, Dow university of Health Sciences Karachi Pakistan
ClinicalTrials.gov Identifier: NCT00698698     History of Changes
Other Study ID Numbers: Tear proteins
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

Keywords provided by Dow University of Health Sciences:
tear proteins
diabetic retinopathy
HPLC
Mass spectroscopy

Additional relevant MeSH terms:
Diabetes Mellitus
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications