Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study on Tear Proteins in Diabetic Retinopathy of Type 2 Diabetics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Dow University of Health Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00698698
First received: June 13, 2008
Last updated: January 30, 2009
Last verified: January 2009
  Purpose

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
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Tear Proteins and Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Dow University of Health Sciences:

Estimated Enrollment: 350
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 13, 2008
Last Updated: January 30, 2009
Health Authority: Pakistan: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014