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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetic Retinopathy

Status

Terminated

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

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

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1 focused on measuring Choroidal blood flow, Laser Doppler flowmetry, Diabetic Retinopathy, Diabetic Neuropathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Arm Description

Patients with long standing IDDM (>10 years) and no diabetic retinopathy

Patients with long standing IDDM (>10 years) and mild non-proliferative diabetic retinopathy

Patients with long standing IDDM (>10 years) and moderate to severe non-proliferative diabetic retinopathy

healthy volunteers, matched for age and sex

Outcomes

Primary Outcome Measures

fundus pulsation amplitude

choroidal blood flow

Secondary Outcome Measures

Nerve conduction velocity

Pupil diameter during infra-red pupillometry

heart rate variability

Full Information

NCT ID

NCT00718614

First Posted

July 7, 2008

Last Updated

November 24, 2014

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00718614

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1, Diabetic Retinopathy

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Patients with long standing IDDM (>10 years) and no diabetic retinopathy

Arm Title

Arm Type

Other

Arm Description

Patients with long standing IDDM (>10 years) and mild non-proliferative diabetic retinopathy

Arm Title

Arm Type

Other

Arm Description

Patients with long standing IDDM (>10 years) and moderate to severe non-proliferative diabetic retinopathy

Arm Title

Arm Type

Other

Arm Description

healthy volunteers, matched for age and sex

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

fundus pulsation amplitude

Time Frame

3 hours

Title

choroidal blood flow

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Nerve conduction velocity

Time Frame

measured before intervention

Title

Pupil diameter during infra-red pupillometry

Time Frame

measured before intervention

Title

heart rate variability

Time Frame

measured before intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhoefer, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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

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