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

NCT00718614 | Terminated DMC

• 1 other identifier: OPHT-300505-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy

Keywords

Choroidal blood flow; Laser Doppler flowmetry; Diabetic Retinopathy; Diabetic Neuropathy

Outcome Measures

Primary Outcomes (2)

• fundus pulsation amplitude

  3 hours

• choroidal blood flow

  3 hours

Secondary Outcomes (3)

• Nerve conduction velocity

  measured before intervention

• Pupil diameter during infra-red pupillometry

  measured before intervention

• heart rate variability

  measured before intervention

Study Arms (4)

1

OTHER

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.

2

OTHER

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.

3

OTHER

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.

4

OTHER

healthy volunteers, matched for age and sex

Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

Interventions

Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. PROCEDURE

Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.

1; 2; 3; 4

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gerhard Garhoefer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. - Doz. Dr

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 18, 2008
• Study Start: June 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

AU (1)