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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00718614
First received: July 7, 2008
Last updated: July 16, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
Diabetic Retinopathy
Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With IDDM

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • fundus pulsation amplitude [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • choroidal blood flow [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nerve conduction velocity [ Time Frame: measured before intervention ] [ Designated as safety issue: No ]
  • Pupil diameter during infra-red pupillometry [ Time Frame: measured before intervention ] [ Designated as safety issue: No ]
  • heart rate variability [ Time Frame: measured before intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718614

Contacts
Contact: Gerhard Garhoefer, MD 00431 40400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gabriele Fuchsjaeger-Mayrl, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00718614     History of Changes
Other Study ID Numbers: OPHT-300505-2
Study First Received: July 7, 2008
Last Updated: July 16, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Choroidal blood flow
Laser Doppler flowmetry
Diabetic Retinopathy
Diabetic Neuropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on July 26, 2014