Diabetes MellitusNCT00698698
Study on Tear Proteins in Diabetic Retinopathy of Type 2 Diabetics
An observational study of Diabetes Mellitus, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 350 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: diabetic population
Who may be able to join
- diabetic patients with type 2 diabetes
- age above 30
- willing to participate
Who cannot join
- ocular surface disorders.
- collagen vascular diseases
- Limbal hyperemia
- previous ocular surgery
- creatinine level above 1.0
- liver diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tear Proteins and Diabetic Retinopathy
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Keywords
- tear proteins, diabetic retinopathy, HPLC, Mass spectroscopy
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Jamshed Ahmed, FCPS, Principal investigator, Dow University of Health Sciences Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698698
- Sponsor's protocol ID
- Tear proteins
- Status last verified
- Jan 2009
- First submitted
- 13 Jun 2008
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Proteins and Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00698698
- Acronym / sponsor ID
- Tear proteins
- Conditions
- Diabetes Mellitus
- Keywords
- tear proteins, diabetic retinopathy, HPLC, Mass spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic population
Key inclusion criteria (3 listed)
- diabetic patients with type 2 diabetes
- age above 30
- willing to participate
Key exclusion criteria (6 listed)
- ocular surface disorders.
- collagen vascular diseases
- Limbal hyperemia
- previous ocular surgery
- creatinine level above 1.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Jamshed Ahmed, FCPS principal investigator
Dow University of Health Sciences Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2009.