Diabetes Mellitus Type 2Phase 3NCT00600236
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
A Phase 3 study testing blood sample in people with Diabetes Mellitus Type 2 and Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Proliferative Diabetic Retinopathy
- What is being tested?
- blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2004to Jan 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Systemic hipertension
- Cardic disease
- Lupus
- Any kind of artritis
- Allergies
- Optic Neuritis
Show all 9Show fewer
- VKH
- Cancer
- Inmunological diseases
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México, Hospital "Luis Sanchez Bulnes"
Mexico City, Mexico DF, 04030
About this study
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.
- Being tested
- blood sample
- Keywords
- Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy, Diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startSep 2004
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Referencia Epidemiológica (INdRE)
- Responsible party
- Sponsor
- Investigators
- Hugo Quiroz-Mercado, MD, Principal investigator, Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600236
- Sponsor's protocol ID
- APEC-0018
- Status last verified
- May 2024
- First submitted
- 30 Jun 2006
- Last updated
- 3 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
- ClinicalTrials.gov ID
- NCT00600236
- Acronym / sponsor ID
- APEC-0018
- Keywords
- Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy, Diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Collaborators
- Instituto Nacional de Referencia Epidemiológica (INdRE)
- Study start
- Sep 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 24 Jan 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Systemic hipertension
- Cardic disease
- Lupus
- Any kind of artritis
- Allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
Hugo Quiroz-Mercado, MD principal investigator
Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing blood sample in people with Diabetes Mellitus Type 2 and Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Jun 2024. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 3 Jun 2024.