Diabetic RetinopathyD&DNCT03403283
Dyslipidemia and Diabetic Retinopathy
An observational study of Diabetic Retinopathy and Dyslipidemia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Dyslipidemia
- What is being tested?
- 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 30 Apr 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ophthalmology and Primary Care Clinics
Who may be able to join
- Any man or woman
- Greater than 18 years of age
- Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type
- The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children.
Who cannot join
- Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test.
- Have retinal abnormalities other than diabetic retinopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.
Read the detailed description
The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.
- Conditions
- Diabetic Retinopathy, Dyslipidemia
- Being tested
- 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy, Healthy Controls 15 age matched control subjects
- Medical subject headings
- Diabetic Retinopathy, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic RetinopathyOther
Also called NPDR - Non Proliferative Diabetic Retinopathy, PDR -Proliferative Diabetic Retinopathy
Healthy Controls 15 age matched control subjectsOther
| Study group | Role | What they receive |
|---|---|---|
| Diabetic | Diabetics with mild, moderate or severe non proliferative retinopathy and proliferative retinopathy Receives: Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy | |
| Controls | Healthy Controls Receives: Other: Healthy Controls 15 age matched control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)
Peripheral blood of 150 cc, about 8-10 tablespoons will be collected from vein in the arm of both diabetic and control subjects.ASM activity was measured on a scale of 0-0.6. 0.6 is worse with units being nM/hr
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study startJan 2014
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Maria Grant, University of Alabama at Birmingham
- Investigators
- Maria B Grant, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403283
- Sponsor's protocol ID
- 300000188
- Other IDs
- 5R01EY016077
- Acronym
- D&D
- Status last verified
- May 2024
- First submitted
- 7 Aug 2014
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia and Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03403283
- Acronym / sponsor ID
- D&D / 300000188
- Conditions
- Diabetic Retinopathy, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jan 2014
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.
Detailed description
The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic | – | Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic RetinopathyDiabetics with mild, moderate or severe non proliferative retinopathy and proliferative retinopathy |
| Controls | – | Other: Healthy Controls 15 age matched control subjectsHealthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology and Primary Care Clinics
Key inclusion criteria (4 listed)
- Any man or woman
- Greater than 18 years of age
- Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type
- The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children.
Key exclusion criteria (2 listed)
- Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test.
- Have retinal abnormalities other than diabetic retinopathy.
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 |
|---|---|---|
| 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic RetinopathyAlso: NPDR - Non Proliferative Diabetic Retinopathy, PDR -Proliferative Diabetic Retinopathy | Other | Diabetic |
| Healthy Controls 15 age matched control subjects | Other | Controls |
Primary outcome
Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)
Time frame: 3 years
Peripheral blood of 150 cc, about 8-10 tablespoons will be collected from vein in the arm of both diabetic and control subjects.ASM activity was measured on a scale of 0-0.6. 0.6 is worse with units being nM/hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maria B Grant, MD principal investigator
University of Alabama at Birmingham
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 Diabetic Retinopathy and Dyslipidemia, run by University of Alabama at Birmingham at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 21 May 2024.