Type-2 DiabetesNCT01440660
Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)
An observational study of Type-2 Diabetes and Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type-2 Diabetes, Diabetic Retinopathy
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2012to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 20 patients, male and female over 18 years-old, with type-2 diabetes mellitus and NPDR with signs of DR progression (RT increase and/or MA turnover) (according to the inclusion/exclusion criteria).
Who may be able to join
- Age over 18 years-old.
- Diabetes mellitus type 2 according to 1985 WHO criteria.
- Non-proliferative diabetic retinopathy (ETDRS level <= 35)
- Signs of NPDR progression based on existing clinical information:
- Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring (leaking phenotype); OR
- Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate >= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software (ischemic phenotype).
- Informed consent.
Who cannot join
- Cataract or other eye disease that may interfere with fundus examinations
- Any eye surgery or treatment within a period of 6-months.
- Pregnant or nursing (lactating) women.
- Patients with chronic or severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2).
- Patients with acute kidney injury.
- Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
- Patients around the time of liver transplantation..
- Patients with implants containing metals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotypes of Nonproliferative Diabetic Retinopathy in Diabetes Type 2 Patients Identified by Optical Coherence Tomography, Colour Fundus Photography, Fluorescein Leakage and Multifocal Electrophysiology (DIAMARKER Project: Genetic Susceptibility for Multi-systemic Complications in Diabetes Type-2: New Biomarkers for Diagnostic and Therapeutic Monitoring).
To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.
- Conditions
- Type-2 Diabetes, Diabetic Retinopathy
- Medical subject headings
- 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 |
|---|---|---|
| Leaking Phenotype | Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring. | |
| Ischemic Phenotype | Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate >= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multimodal testing/imaging procedures - Ophthalmological Imaging
Retinal thickness measured with OCT;
Measured: 24 months
Multimodal testing/imaging procedures - Ophthalmological Imaging
MA turnover computed based on CFP.
Measured: 24 months
Multimodal testing/imaging procedures - Ophthalmological Imaging
Macular area with increased retinal fluorescein leakage based on RLA.
Measured: 12 months
Multimodal testing/imaging procedures - Ophthalmological Imaging
Implicit time local and ring amplitudes measured with mfERG.
Measured: 12 months
Multimodal testing/imaging procedures - Psychophysical Testing
Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.
Measured: 12 months
Multimodal testing/imaging procedures - Barin Imaging
Perfusion change measured with ASL.
Measured: 12 months
Multimodal testing/imaging procedures - Ophthalmological Imaging
Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.
Measured: 12 months
Multimodal testing/imaging procedures - Brain Imaging
Metabolite concentrations assessed with MR Spectroscopy.
Measured: 12 months
Secondary outcomes (1)
Multimodal testing/ imaging modalities (raw data)
Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 DiabetesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Collaborators
- University of Coimbra
- Responsible party
- Sponsor
- Investigators
- José Cunha-Vaz, MD PhD, Study chair, Association for Innovation and Biomedical Research on Light and ImageMiguel Castelo-Branco, MD PhD, Study chair, FMUCLuísa Ribeiro, MD MSc, Principal investigator, AIBILI - CEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440660
- Sponsor's protocol ID
- 4C-2011-01
- Status last verified
- Oct 2015
- First submitted
- 22 Sep 2011
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypes of Nonproliferative Diabetic Retinopathy in Diabetes Type 2 Patients Identified by Optical Coherence Tomography, Colour Fundus Photography, Fluorescein Leakage and Multifocal Electrophysiology (DIAMARKER Project: Genetic Susceptibility for Multi-systemic Complications in Diabetes Type-2: New Biomarkers for Diagnostic and Therapeutic Monitoring).
- ClinicalTrials.gov ID
- NCT01440660
- Acronym / sponsor ID
- 4C-2011-01
- Conditions
- Type-2 Diabetes, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Collaborators
- University of Coimbra
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Sep 2011 (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.
To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leaking Phenotype | – | –Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring. |
| Ischemic Phenotype | – | –Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate >= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 20 patients, male and female over 18 years-old, with type-2 diabetes mellitus and NPDR with signs of DR progression (RT increase and/or MA turnover) (according to the inclusion/exclusion criteria).
Key inclusion criteria (7 listed)
- Age over 18 years-old.
- Diabetes mellitus type 2 according to 1985 WHO criteria.
- Non-proliferative diabetic retinopathy (ETDRS level <= 35)
- Signs of NPDR progression based on existing clinical information:
- Informed consent.
Key exclusion criteria (8 listed)
- Cataract or other eye disease that may interfere with fundus examinations
- Any eye surgery or treatment within a period of 6-months.
- Pregnant or nursing (lactating) women.
- Patients with chronic or severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2).
- Patients with acute kidney injury.
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
Multimodal testing/imaging procedures - Ophthalmological Imaging
Time frame: 24 months
Retinal thickness measured with OCT;
Multimodal testing/imaging procedures - Ophthalmological Imaging
Time frame: 24 months
MA turnover computed based on CFP.
Multimodal testing/imaging procedures - Ophthalmological Imaging
Time frame: 12 months
Macular area with increased retinal fluorescein leakage based on RLA.
Multimodal testing/imaging procedures - Ophthalmological Imaging
Time frame: 12 months
Implicit time local and ring amplitudes measured with mfERG.
Multimodal testing/imaging procedures - Psychophysical Testing
Time frame: 12 months
Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.
Multimodal testing/imaging procedures - Barin Imaging
Time frame: 12 months
Perfusion change measured with ASL.
Multimodal testing/imaging procedures - Ophthalmological Imaging
Time frame: 12 months
Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.
Multimodal testing/imaging procedures - Brain Imaging
Time frame: 12 months
Metabolite concentrations assessed with MR Spectroscopy.
1 secondary outcome
Multimodal testing/ imaging modalities (raw data)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
Related trials for Type-2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
José Cunha-Vaz, MD PhD study chair
Association for Innovation and Biomedical Research on Light and Image
Miguel Castelo-Branco, MD PhD study chair
FMUC
Luísa Ribeiro, MD MSc principal investigator
AIBILI - CEC
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 Type-2 Diabetes and Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
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 7 inclusion and 8 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 8 Oct 2015. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multimodal testing/imaging procedures - Ophthalmological Imaging (time frame: 24 months). The study lists 8 primary outcomes in all. 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 8 Oct 2015.