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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718614
• Other study ID #: OPHT-300505-2
• Status: Terminated
• Phase: N/A
• First received: July 7, 2008
• Last updated: November 24, 2014
• Start date: June 2007
• Est. completion date: July 2007

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fundus pulsation amplitude		3 hours	No
Primary	choroidal blood flow		3 hours	No
Secondary	Nerve conduction velocity		measured before intervention	No
Secondary	Pupil diameter during infra-red pupillometry		measured before intervention	No
Secondary	heart rate variability		measured before intervention	No