NCT00698698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 2, 2009

Status Verified

January 1, 2009

Enrollment Period

1.9 years

First QC Date

June 13, 2008

Last Update Submit

January 30, 2009

Conditions

Diabetes Mellitus

Keywords

tear proteinsdiabetic retinopathyHPLCMass spectroscopy

Study Arms (5)

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

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic population

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Dr. Jamshed Ahmed, FCPS

    Dow University of Health Sciences Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 17, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

February 2, 2009

Record last verified: 2009-01

Locations

PA(1)