Retinal Blood Flow and Microthrombi in Type 1 Diabetes - Full Text View

Sponsor:	Schepens Eye Research Institute
Information provided by:	Schepens Eye Research Institute
ClinicalTrials.gov Identifier:	NCT00406991

Purpose

The project aims to find mechanisms for the abnormal retinal blood flow that in diabetic patients often precedes any evidence of clinical retinopathy and may contribute to the development of retinopathy.

Specifically, the projects tests the hypothesis that reduced retinal blood flow found in young patients with type 1 diabetes reflects increased resistance in the small vessels of the retina caused by the formation of small blood clots, called microthrombi; and that antiplatelet agents normalize the reduced retinal blood flow.

Condition	Intervention	Phase
Diabetes Diabetic Retinopathy	Drug: aspirin Drug: clopidogrel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Retinal Blood Flow and Microthrombi in Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Type 1 Diabetic Eye Problems Retinal Disorders

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Schepens Eye Research Institute:

Primary Outcome Measures:

Retinal blood flow

Secondary Outcome Measures:

Retinal arterial blood speed
Retinal arterial diameter

Estimated Enrollment:	100
Study Start Date:	June 2003
Estimated Study Completion Date:	March 2006

Detailed Description:

The ultimate goal of this research is to contribute to the development of strategies to prevent diabetic retinopathy. This project will test the hypothesis that antiplatelet agents normalize the reduced blood flow observed early in the course of type 1 diabetes. If the hypothesis is proven correct, the results will indicate that the formation of small blood clots (microthrombi) occurs early in diabetic retinal vessels. In turn, because microthrombosis could readily account for the occlusive microangiopathy that causes the sight-threatening stages of diabetic retinopathy, the results will propose the desirability of antiplatelet therapy for the prevention of diabetic retinopathy.

We have three specific aims:

To confirm that, under basal conditions, retinal blood flow measured with the laser Doppler method in a group of type 1 diabetic patients with no or minimal retinopathy differs from the flow measured in age- and sex-matched nondiabetic control subjects;
To determine whether the response of retinal blood flow to low-dose aspirin (81 mg/day) administered for 2 months versus placebo, differs between type 1 diabetic patients with no or minimal retinopathy and age- and sex-matched nondiabetic control subjects;
To determine whether in type 1 diabetic patients with no or minimal retinopathy the response of retinal blood flow to low-dose aspirin differs from the response to clopidogrel, a drug that interferes with platelet function downstream of the site of aspirin action.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-45 years,
type 1 diabetes duration 1-15 years,
absent or minimal retinopathy (EDTRS 20).
Age- and gender-matched healthy controls

Exclusion Criteria:

smoking,
systemic diseases other than diabetes,
retinal diseases other than diabetic retinopathy,
pregnancy,
bleeding disorders,
aspirin allergy,
use of anti-platelet agents,
non-steroidal anti-inflammatory agents,
angiotensin converting enzyme inhibitors,
angiotensin receptor antagonists,
Vitamin E in large doses.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406991

Locations

United States, Massachusetts
Schepens Eye Research Institute
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Schepens Eye Research Institute

Investigators

Principal Investigator:

Mara Lorenzi, MD

Schepens Eye Research Institute

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00406991 History of Changes
Other Study ID Numbers:	2002-015, 2003P-000224, EY014812
Study First Received:	November 30, 2006
Last Updated:	December 1, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schepens Eye Research Institute:

retinal blood flow
diabetic retinopathy
microthrombosis
aspirin
clopidogrel

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
Aspirin

Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012