Advanced Glycation End Products as a Biomarker for Accelerated Ageing

Sponsor
University of Plymouth (Other)
Overall Status
Completed
CT.gov ID
NCT02863224
Collaborator
(none)
131
1
25
5.2

Study Details

Study Description

Brief Summary

Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is advancing age. The rate of ageing is not the same in all age matched individuals. The concept of accelerated ageing suggests that the presence of a number of specific genetic, environmental or systemic risk factors may cumulate to accelerate the ageing process in some individuals and lead to the development of age-related disease. Understanding the factors that influence accelerated ageing is vital.

Advanced glycation end products (AGEs) are a complex group of compounds that are naturally formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the body where they adversely affect structure and function. Circulating AGE levels can be influenced by oxidative stress levels and dietary intake. Recent research has found that sustained exposure to high levels of circulating AGEs could be a major factor in the development of a number of chronic age-related degenerative disorders, including POAG.

To date there have been few clinical studies that have been able to non-invasively explore the association between AGE levels and the development and progression of glaucomatous optic neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary intake make to total tissue AGE levels in such patients. Furthermore little is understood about the relationship between AGE levels and retinal vascular function, a parameter known to be altered in GON that also could be influenced by AGE levels.

The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with parameters of retinal vascular function, oxidative stress, dietary intake and the presence of GON. Establishing this association could increase our understanding of the pathogenesis of GON and allow a new biomarker for accelerated ocular ageing to be realised

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    131 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Advanced Glycation End Products as a Biomarker for Accelerated Ageing in Glaucomatous Optic Neuropathy
    Actual Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Sep 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy control

    Ocular hypertension

    Primary open angle glaucoma

    Normal tension glaucoma

    Outcome Measures

    Primary Outcome Measures

    1. Tissue bound AGE level (AU) [Tissue bound AGE level (AU) will be measured for each participant at their second session (within 3 months of volunteering).]

      Level of AGE found in the skin - measured from the lower portion of the arm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Must have had an eye test within the last two years

    • Aged 50+

    • Informed, written consent

    • Have adequate understanding of English language to be able to comprehend the oral and written instructions.

    • Participants must be able to complete a 12-hour overnight fast, which includes no alcohol or caffeine.

    Inclusion criteria for Ocular hypertension, Primary open angle glaucoma and normal tension glaucoma:

    • Follows guidelines set out within the protocol and used at Derriford REI
    Exclusion Criteria:
    • Diabetes

    • Current smokers

    • History of stroke/TIA

    • Coronary artery disease/heart failure/arrhythmia/angina

    • Peripheral vascular disease

    • Severe dyslipidaemia

    • Hyper/hypothyroidism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Plymouth University Plymouth Devon United Kingdom PL4 8AA

    Sponsors and Collaborators

    • University of Plymouth

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leanne Smewing, Principal Investigator, University of Plymouth
    ClinicalTrials.gov Identifier:
    NCT02863224
    Other Study ID Numbers:
    • 204642
    First Posted:
    Aug 11, 2016
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019

    Study Results

    No Results Posted as of Apr 16, 2019