Diabetic Macular OedemaNCT00333671
Quantification of Rising the Osmotic Pressure in Diabetic Intraretinal Fluid Accumulation (Diabetic Macular Oedema)
A study testing Glycerol in people with Diabetic Macular Oedema, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Diabetic macular oedema is characterized by fluid accumulation in the retinal tissue from leaking retinal vessels, the capillaries. This state can lead to severe visual loss and blindness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- Glycerol
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2004to Apr 2007
- Phase
- Interventional
- 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
- Diabetic significant macular oedema (by biomicroscopy or OCT)
- Visual acuity of minimum 60 letters by the ETDRS chart (4 m distance)
- ETDRS grade between 35 and 53, both stages included
- baseline blood pressure of max. 160/90 mmHg
- informed consent
Who cannot join
- another macular disease than diabetic macular oedema to explain the symptoms, incl. prior laser photocoagulation
- pregnancy
- moderate to severe heart or lung disease (crural oedemas, dyspnoea during low activity, or basal crackles by lung stethoscopy
- renal insufficiency with albumin excretion larger than 300 g/day
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75
Herlev, DK-2730
About this study
Official title: Diabetic Macular Oedema: the Retinal Thickness as a Function of Changes in Plasma Osmolality Evaluated by OCT.
Diabetic macular oedema is characterized by fluid accumulation in the retinal tissue from leaking retinal vessels, the capillaries. This state can lead to severe visual loss and blindness. According to basic physiologic rules several factors influence the fluid transport between the capillaries and the surrounding tissue. One of these factors is the balance between the large molecules within the vessel lumen and the retinal tissue. Some drugs change this balance, the osmotic balance, by moving the fluid from the tissue to the vessel lumen. In relation to diabetic macular oedema, treatment with such a drug potentially would reduce the retinal thickness because it extracts fluid from the retinal tissue. Glycerol has this potential. If reduction of the thickness with glycerol is confirmed, then it proves the significance of the osmotic balance in the basic nature of diabetic macular oedema.
In this study we therefore examine the time dependent change in retinal thickness after glycerol intake by an instrument called optical coherence tomography (OCT). The participants drink glycerol and the thickness of the retina is then monitored closely by OCT during the following three hours. Since diabetic changes in the retina are focal pr. definition, the secondary purpose of the study is to find any regional differences in the response. The examinations are repeated at a second visit where the patient drink another dose of glycerol, because we also want to analyse for a dose dependent response. Which dose is given at each visit is randomised on beforehand. In addition to measuring the retinal thickness a variety of examinations are performed both before and during the study, e.g. blood samples and systemic blood pressure measurements.
Read the detailed description
In general, when oedema is present, increasing the osmotic pressure in the retinal capillaries by an osmotic drug induces transcapillary fluid transport from the retinal tissue to the vascular lumen, according to the Starling equation. Theoretically, in diabetic macular oedema the event would lead to reduction of the retinal thickness, which could then be visualised by Optical Coherence Tomography. The main purpose of this trial is therefore to evaluate and quantify the changes in retinal thickness of the oedema after increasing the intracapillary osmotic pressure with glycerol ingestion. A reduction of the retinal thickness will confirm the application of the Starling osmotic forces on diabetic macular oedema. Secondly, we want to describe any regional differences in the retinal response and analyse for dose dependent variations.
Principles of material and methods: A prospective, randomized, clinical trial on 15 patients with diabetic significant macular oedema. At baseline the patients undergo a thorough ophthalmologic examination including ETDRS visual acuity, slit lamp biomicroscopy, Optical Coherence Tomography (Stratus-OCT), 7-field fundus photography followed by fluorescein angiography. In addition the systemic blood pressure is measured and blood samples are taken to rule out severe renal insufficiency and to estimate glycosylated haemoglobin.
The patients are all randomised to drink either 1.5 or 3 mL glycerol/kg body weight (max. 250 mL pr day) on the first of two visit dates. The last dose is given at the second visit. In the following three hours the retinal thickness is then monitored closely by Stratus-OCT after the glycerol ingestion.
The plasma osmolality and plasma triglyceride (an indirect indicator of glycerol) are confirmed by venous blood samples, also at predetermined times after the last swallow of glycerol. In addition the systemic blood pressure and the capillary blood glucose are monitored closely during the visit.
- Conditions
- Diabetic Macular Oedema
- Being tested
- Glycerol
- Keywords
- Macular oedema, Diabetes, Pathogenesis, Osmolality, Retinal thickness
- Medical subject headings
- Macular Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycerolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol.
Secondary outcomes (2)
Regional differences in response by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol
dose dependent differences in the same time spectrum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startDec 2004
- Primary completionFeb 2006
- Study completionApr 2007
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 Diabetic Macular OedemaStudies 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 N/A
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgit Sander, Glostrup University Hospital, Copenhagen
- Investigators
- Dorte Nellemann Thornit, MD, Principal investigator, Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333671
- Sponsor's protocol ID
- Dorte Nellemann, glycerol
- Status last verified
- Sep 2012
- First submitted
- 2 Jun 2006
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Thornit DN, Vinten CM, Sander B, Lund-Andersen H, la Cour M. Blood-retinal barrier glycerol permeability in diabetic macular edema and healthy eyes: estimations from macular volume changes after peroral glycerol. Invest Ophthalmol Vis Sci. 2010 Jun;51(6):2827-34. doi: 10.1167/iovs.09-4172. Epub 2009 Dec 30.
PubMed 20042642
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Macular Oedema: the Retinal Thickness as a Function of Changes in Plasma Osmolality Evaluated by OCT.
- ClinicalTrials.gov ID
- NCT00333671
- Acronym / sponsor ID
- Dorte Nellemann, glycerol
- Conditions
- Diabetic Macular Oedema
- Keywords
- Macular oedema, Diabetes, Pathogenesis, Osmolality, Retinal thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 6 Jun 2006 (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.
Diabetic macular oedema is characterized by fluid accumulation in the retinal tissue from leaking retinal vessels, the capillaries. This state can lead to severe visual loss and blindness. According to basic physiologic rules several factors influence the fluid transport between the capillaries and the surrounding tissue. One of these factors is the balance between the large molecules within the vessel lumen and the retinal tissue. Some drugs change this balance, the osmotic balance, by moving the fluid from the tissue to the vessel lumen. In relation to diabetic macular oedema, treatment with such a drug potentially would reduce the retinal thickness because it extracts fluid from the retinal tissue. Glycerol has this potential. If reduction of the thickness with glycerol is confirmed, then it proves the significance of the osmotic balance in the basic nature of diabetic macular oedema.
In this study we therefore examine the time dependent change in retinal thickness after glycerol intake by an instrument called optical coherence tomography (OCT). The participants drink glycerol and the thickness of the retina is then monitored closely by OCT during the following three hours. Since diabetic changes in the retina are focal pr. definition, the secondary purpose of the study is to find any regional differences in the response. The examinations are repeated at a second visit where the patient drink another dose of glycerol, because we also want to analyse for a dose dependent response. Which dose is given at each visit is randomised on beforehand. In addition to measuring the retinal thickness a variety of examinations are performed both before and during the study, e.g. blood samples and systemic blood pressure measurements.
Detailed description
In general, when oedema is present, increasing the osmotic pressure in the retinal capillaries by an osmotic drug induces transcapillary fluid transport from the retinal tissue to the vascular lumen, according to the Starling equation. Theoretically, in diabetic macular oedema the event would lead to reduction of the retinal thickness, which could then be visualised by Optical Coherence Tomography. The main purpose of this trial is therefore to evaluate and quantify the changes in retinal thickness of the oedema after increasing the intracapillary osmotic pressure with glycerol ingestion. A reduction of the retinal thickness will confirm the application of the Starling osmotic forces on diabetic macular oedema. Secondly, we want to describe any regional differences in the retinal response and analyse for dose dependent variations.
Principles of material and methods: A prospective, randomized, clinical trial on 15 patients with diabetic significant macular oedema. At baseline the patients undergo a thorough ophthalmologic examination including ETDRS visual acuity, slit lamp biomicroscopy, Optical Coherence Tomography (Stratus-OCT), 7-field fundus photography followed by fluorescein angiography. In addition the systemic blood pressure is measured and blood samples are taken to rule out severe renal insufficiency and to estimate glycosylated haemoglobin.
The patients are all randomised to drink either 1.5 or 3 mL glycerol/kg body weight (max. 250 mL pr day) on the first of two visit dates. The last dose is given at the second visit. In the following three hours the retinal thickness is then monitored closely by Stratus-OCT after the glycerol ingestion.
The plasma osmolality and plasma triglyceride (an indirect indicator of glycerol) are confirmed by venous blood samples, also at predetermined times after the last swallow of glycerol. In addition the systemic blood pressure and the capillary blood glucose are monitored closely during the visit.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic significant macular oedema (by biomicroscopy or OCT)
- Visual acuity of minimum 60 letters by the ETDRS chart (4 m distance)
- ETDRS grade between 35 and 53, both stages included
- baseline blood pressure of max. 160/90 mmHg
- informed consent
Key exclusion criteria (4 listed)
- another macular disease than diabetic macular oedema to explain the symptoms, incl. prior laser photocoagulation
- pregnancy
- moderate to severe heart or lung disease (crural oedemas, dyspnoea during low activity, or basal crackles by lung stethoscopy
- renal insufficiency with albumin excretion larger than 300 g/day
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 |
|---|---|---|
| Glycerol | Drug | – |
Primary outcome
Retinal thickness by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol.
2 secondary outcomes
Regional differences in response by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol
dose dependent differences in the same time spectrum.
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 19 Sep 2012.
- Derived from this study: PubMed 20042642Thornit DN, Vinten CM, Sander B, Lund-Andersen H, la Cour M. Blood-retinal barrier glycerol permeability in diabetic macular edema and healthy eyes: estimations from macular volume changes after peroral glycerol. Invest Ophthalmol Vis Sci. 2010 Jun;51(6):2827-34. doi: 10.1167/iovs.09-4172. Epub 2009 Dec 30.
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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.
Dorte Nellemann Thornit, MD principal investigator
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycerol in people with Diabetic Macular Oedema, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 5 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 19 Sep 2012. 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 Denmark. 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?
Retinal thickness by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol.. 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 NCT00333671, 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 19 Sep 2012.