Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With Insulin-dependent Diabetes Mellitus (IDDM)

November 24, 2014 updated by: Gerhard Garhofer, Medical University of Vienna

Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With IDDM

There is evidence from a variety of animal studies that choroidal blood flow is under neural control. Recent results in humans indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. Several observations indicate that the changes in choroidal perfusion are triggered at least in part by neural mechanisms. Particularly, we have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism for blood flow regulation. Investigation of changes in choroidal blood flow during light/dark transition may represent an interesting approach to study neural dysregulation at the level of the eye in patients with IDDM. Accordingly, the hypothesis of reduced choroidal blood flow responses to a light/dark transition in patient with IDDM will be tested. This response in choroidal blood flow will be correlated to parameters of diabetic neuropathy and diabetic retinopathy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For healthy control subjects:

  • Men and women aged over 18 years, matched in regard to age, sex and smoking status
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, Ametropia < 3 dpt for healthy control subjects

For patients with IDDM:

  • Men and women aged over 18 years
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Long standing IDDM > 10 years
  • Mild or moderate to severe non-proliferative diabetic retinopathy (defined according to the MAHC)
  • Ametropia < 3 dpt

Exclusion Criteria:

Any of the following will exclude a healthy subject from the study:

  • Regular use of vasoactive medication with may interfere with the study procedure, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks

Any of the following will exclude a patient with IDDM from the study:

  • Evidence of any relevant retinal or choroidal disease (Glaucoma, age related macula degeneration, cataract, history of central retinal artery obstruction or central retinal vein thrombosis)
  • Ophthalmological surgery (history of photo laser coagulation, including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy)
  • History of intravitreal injection with anti-proliferative therapy
  • Need for dialysis
  • Non-treated systemic hypertension (SPB>150, DBP>95)
  • Evidence of coronary heart disease, cardiomyopathy, stenocardia, congestive heart failure, peripheral occlusive vascular disease, cardiac autonomic neuropathy
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Patients with long standing IDDM (>10 years) and no diabetic retinopathy
Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Other: 2
Patients with long standing IDDM (>10 years) and mild non-proliferative diabetic retinopathy
Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Other: 3
Patients with long standing IDDM (>10 years) and moderate to severe non-proliferative diabetic retinopathy
Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Other: 4
healthy volunteers, matched for age and sex
Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fundus pulsation amplitude
Time Frame: 3 hours
3 hours
choroidal blood flow
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Nerve conduction velocity
Time Frame: measured before intervention
measured before intervention
Pupil diameter during infra-red pupillometry
Time Frame: measured before intervention
measured before intervention
heart rate variability
Time Frame: measured before intervention
measured before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (Estimate)

July 18, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-300505-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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