NCT04025996

Brief Summary

Retinopathy may be associated with diastolic dysfunction and/or coronary flow reserve in the heart, and albuminuria in diabetic patients. The objective of this study is to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

February 3, 2021

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

April 4, 2018

Last Update Submit

February 2, 2021

Conditions

Retinopathy, DiabeticDiastolic DysfunctionMicroalbuminuria

Outcome Measures

Primary Outcomes (2)

  • Eye Examination

    Retinal photography on diabetic patients will be performed to identify those with retinopathy.

    1 day

  • Cross-sectional analyses will be performed to look at the association between diabetic retinopathy with left ventricular diastolic function, coronary flow reserve and urinary albumin excretion.

    These data will provide initial evidence of the mechanistic link between microvascular dysfunction in the eye, heart and kidneys among patients with diabetes.

    2 days

Study Arms (1)

Diseased Group

Patients with type 2 diabetic retinopathy and known cardiac dysfunction.

Diagnostic Test: Cardiac Assessments and Eye Assessments

Interventions

Cardiac Assessments and Eye AssessmentsDIAGNOSTIC_TEST

Cardiac Assessments, include the following: * transthoracic echocardiography * computed tomography of coronary arteries * position emission tomography computed tomography or single photon emission tomography computed tomography Eye examinations, include the following: * pupil dilation * retinal photography * dynamic vessel analyser * IOL master

Diseased Group

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have known heart condition and type II diabetes.

You may qualify if:

  • Age greater than equal to 21 years old

You may not qualify if:

  • Known history of active eye lens or corneal opacity
  • Known allergy to eye drops
  • Kidney disease with estimated GFR \< 60
  • Pregnant or lactating women
  • Asthmatic status of the moderate persistent and above categories
  • Chronic obstructive pulmonary disease
  • Thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Related Publications (5)

  • Phan K, Mitchell P, Liew G, Plant AJ, Wang SB, Au C, Chiha J, Kovoor P, Thiagalingam A, Burlutsky G, Gopinath B. Association between Retinal Arteriolar and Venule Calibre with Prevalent Heart Failure: A Cross-Sectional Study. PLoS One. 2015 Dec 11;10(12):e0144850. doi: 10.1371/journal.pone.0144850. eCollection 2015.

    PMID: 26659133BACKGROUND

  • Wong TY, Rosamond W, Chang PP, Couper DJ, Sharrett AR, Hubbard LD, Folsom AR, Klein R. Retinopathy and risk of congestive heart failure. JAMA. 2005 Jan 5;293(1):63-9. doi: 10.1001/jama.293.1.63.

    PMID: 15632337BACKGROUND

  • Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. doi: 10.1161/CIRCULATIONAHA.106.659763. Epub 2007 Apr 2.

    PMID: 17404159BACKGROUND

  • Lam CS, Lyass A, Kraigher-Krainer E, Massaro JM, Lee DS, Ho JE, Levy D, Redfield MM, Pieske BM, Benjamin EJ, Vasan RS. Cardiac dysfunction and noncardiac dysfunction as precursors of heart failure with reduced and preserved ejection fraction in the community. Circulation. 2011 Jul 5;124(1):24-30. doi: 10.1161/CIRCULATIONAHA.110.979203. Epub 2011 Jun 13.

    PMID: 21670229BACKGROUND

  • Teo LY, Chan LL, Lam CS. Heart failure with preserved ejection fraction in hypertension. Curr Opin Cardiol. 2016 Jul;31(4):410-6. doi: 10.1097/HCO.0000000000000292.

    PMID: 27070649BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Thng Ai Ling Sandra

CONTACT

+65 6704 2279sandra.thng.a.l@nhcs.com.sg

Tan Ying Zhen Janice

CONTACT

+65 6704 2229janice.tan.y.z@nhcs.com.sg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2018

First Posted

July 19, 2019

Study Start

February 20, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

February 3, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)