Status:
TERMINATED
Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With Insulin-dependent Diabetes Mellitus (IDDM)
Lead Sponsor:
Medical University of Vienna
Conditions:
Diabetes Mellitus, Type 1
Diabetic Retinopathy
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00718614
Start Date
June 1 2007
End Date
July 1 2007
Last Update
November 25 2014
Active Locations (1)
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1
Department of Clinical Pharmacology
Vienna, Austria, 1090