NCT00333671

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

June 2, 2006

Last Update Submit

September 18, 2012

Conditions

Diabetic Macular Oedema

Keywords

Macular oedemaDiabetesPathogenesisOsmolalityRetinal thickness

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

GlycerolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75

Herlev, DK-2730, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 20042642DERIVED

MeSH Terms

Conditions

Macular EdemaDiabetes Mellitus

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Dorte Nellemann Thornit, MD

    Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

December 1, 2004

Primary Completion

February 1, 2006

Study Completion

April 1, 2007

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

DK(1)