Diabetes MellitusNCT01771835
Retinal Venous Pressure and ET-1 in Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Nov 2012
- 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: Patients with diabets mellitus type I or II, without diabetic retinopathy
Who may be able to join
- diabetes mellitus type I or II
- no diabetic retinopathy
Who cannot join
- known diabetic retinopathy
- acute or chronic inflammation of the eyes
- narrow angle glaucoma
- minority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus
Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.
Read the detailed description
Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.
In ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, retinal venous pressure, endothelin-1
- Medical subject headings
- Diabetes Mellitus
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 |
|---|---|---|
| Diabetes patients | Patients with diabetes mellitus type I + II, without diabetic retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of retinal venous pressure (RVP)
Measured: 30 minutes
Secondary outcomes (1)
Quantification of ET-1 in correlation with RVP
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josef Flammer, MD, Study director, University of Basel, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771835
- Sponsor's protocol ID
- 089-CYA-2012
- Status last verified
- Jan 2013
- First submitted
- 24 Oct 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cybulska-Heinrich AK, Baertschi M, Loesche CC, Schoetzau A, Konieczka K, Josifova T, Flammer J. Patients with diabetic retinopathy have high retinal venous pressure. EPMA J. 2015 Feb 24;6(1):5. doi: 10.1186/s13167-015-0027-1. eCollection 2015.
PubMed 25793018
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01771835
- Acronym / sponsor ID
- 089-CYA-2012
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, retinal venous pressure, endothelin-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Jan 2013 (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.
Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.
Detailed description
Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.
In ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes patients | – | –Patients with diabetes mellitus type I + II, without diabetic retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabets mellitus type I or II, without diabetic retinopathy
Key inclusion criteria (2 listed)
- diabetes mellitus type I or II
- no diabetic retinopathy
Key exclusion criteria (4 listed)
- known diabetic retinopathy
- acute or chronic inflammation of the eyes
- narrow angle glaucoma
- minority
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
Quantification of retinal venous pressure (RVP)
Time frame: 30 minutes
1 secondary outcome
Quantification of ET-1 in correlation with RVP
Time frame: 30 minutes
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 18 Jan 2013.
- Derived from this study: PubMed 25793018Cybulska-Heinrich AK, Baertschi M, Loesche CC, Schoetzau A, Konieczka K, Josifova T, Flammer J. Patients with diabetic retinopathy have high retinal venous pressure. EPMA J. 2015 Feb 24;6(1):5. doi: 10.1186/s13167-015-0027-1. eCollection 2015.
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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.
Josef Flammer, MD study director
University of Basel, Dept. of Ophthalmology
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 University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 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 18 Jan 2013. 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 Switzerland. 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?
Quantification of retinal venous pressure (RVP) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01771835, which also lists 1 linked publication.
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 18 Jan 2013.