Retinal Vessel Measurements as Clinically Useful Predictors in Veterans

NCT01772173 | Completed

• 1 other identifier: C1084-P
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic complications are an important source of blindness and mortality among Veterans. Their occurrence is unpredictable because of the highly variable effect of factors such as weight, diet and exercise. Improved prediction of diabetes complications has the potential to improve the care for Veterans with diabetes, especially if this can be done without any extra effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are required to undergo annual retinal photography to screen for current diabetic retinopathy. The investigators have recently developed an automated, precise, fast, novel tool for measuring retinal vessels in these images. Manual measurement of retinal vessels has shown that these can predict future -not current- development of hypertension and also diabetic retinopathy. If the investigators can confirm that their tool can flag those Veterans at increased risk for developing these diabetes complications, this will allow earlier intervention and prevention. Because the tool only uses the images that are being taken anyway, there is no extra effort for either the Veteran or VA staff.

Conditions

Diabetes

Keywords

diabetes; computer; retina; vessel; analysis

Outcome Measures

Primary Outcomes (1)

• Area under the Curve of algorithm

  AUC of automatically derived retinal vessel parameters (arterial and retinal vessel width and branch relationships) as an early biomarker for future development of hypertension no less than 2 years later, with normal current normal blood pressure.

  2/1/2016

Study Arms (1)

subjects with diabetes developing hypertension

subjects with diabetes not developing hypertension

Other: Vessel measurements

Interventions

Vessel measurements OTHER

Measurement of retinal vessels

subjects with diabetes developing hypertension

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will identify a random sample of 4500 Veterans with diabetes from the Greater LA and Iowa City screening programs, who were imaged at least 3 years ago for DR screening, and did not have hypertension (AHA definition) at that time

You may qualify if:

• Veterans with diabetes
• from the Greater LA and Iowa City screening programs
• who were imaged at least 3 years ago for DR screening, and did not have hypertension (AHA definition) at that time

You may not qualify if:

• random sample of 500 Veterans with diabetes
• from the Greater LA and Iowa City screening programs
• who were imaged at least 3 years ago for DR screening, and did not have hypertension (AHA definition) at that time

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Biospecimen

Retention: NONE RETAINED

Retinal images - vessel parameters

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Abramoff, MD

  Iowa City VA Health Care System, Iowa City, IA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 21, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)