Restoration of Retinal Vascular Responses in Type 1 Diabetic Patients

NCT02099981 | Completed Phase 1

• 1 other identifier: Protocol 22503
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of the disease are poorly understood. One of the earliest changes that occur in the retinas of diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked increases in blood flow in retinal vessels. The loss of this vascular response may lead to retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic retinopathy. The long-term goals of this project are to determine whether decreased blood flow in diabetic patients and the resulting retinal hypoxia contributes to the development of diabetic retinopathy and whether restoration of normal blood flow in diabetic patients slows or prevents the development of retinopathy.

Conditions

Diabetic Retinopathy

Keywords

Diabetes; Diabetic; Retinopathy; Ophthalmology; Eye; Eyes

Outcome Measures

Primary Outcomes (1)

• The vascular response to flicker

  The vascular response will be defined as the ratio of the maximal vessel diameter observed during the stimulation period, compared to the mean diameter during the control period

  90 minutes

Secondary Outcomes (1)

• Contrast sensitivity

  90 minutes

Study Arms (2)

Control Group

EXPERIMENTAL

Control subjects will receive AG.

Drug: Aminoguanidine

Type 1 diabetes

EXPERIMENTAL

Type 1 diabetic subjects will receive AG.

Drug: Aminoguanidine

Interventions

Aminoguanidine DRUG

Also known as: AG

Control Group; Type 1 diabetes

Eligibility Criteria

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

You may qualify if:

• Type 1 diabetes between 18 and 65 years of age
• Diabetes duration between 5 to 20 years.
• Normal report or minor findings on a dilated eye exam
• Healthy subjects on no medications

You may not qualify if:

• Current diagnosis or history of:
• hypertension
• dyslipidemia
• epilepsy
• glaucoma or other ocular disease
• renal insufficiency/failure (creatinine \>1.5 mg/dL)
• pregnancy or breastfeeding.
• smoker

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus; Retinal Diseases

Interventions

pimagedine

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elizabeth Seaquist, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: March 31, 2014
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

US (1)