NCT02947555

Brief Summary

The rate of lens autofluorescence will be compared in diabetic and non diabetic patients with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk of cardiovascular diseases.

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
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

3.7 years

First QC Date

September 22, 2016

Last Update Submit

February 22, 2019

Conditions

Diabetic Patients With/Without Atherosclerotic Diseases

Keywords

diabetes mellitusatherosclerosisAGElens autofluorescence

Outcome Measures

Primary Outcomes (1)

  • Association of lens autofluorescence with atherosclerotic vascular events

    Measurement of the autofluorescence of lens proteins and assessement of its association with the occurrance of atherosclerotic vascular events

    2 years

Secondary Outcomes (6)

  • Association of lens autofluorescence with the perscene of diabetes

    2 years

  • Association of lens autofluorescence with renal function

    2 years

  • Association of lens autofluorescence with glucose metabolism parameteres

    2 years

  • Association of lens autofluorescence with lipid profile

    2 years

  • Association of lens autofluorescence with CRP

    2 years

  • +1 more secondary outcomes

Study Arms (4)

DM+/AT+

Patients with type 2 diabetes mellitus and atherosclerotic event in history

Other: Non interventional

DM+/AT-

Patients with type 2 diabetes mellitus without atherosclerotic event in history

Other: Non interventional

DM-/AT+

Non-diabetic patients with atherosclerotic event in history

Other: Non interventional

DM-/AT-

Non-diabetic patients without atherosclerotic event in history

Other: Non interventional

Interventions

Non interventionalOTHER
DM+/AT+DM+/AT-DM-/AT+DM-/AT-

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (ACS, angina pectoris, stroke, TIA, clinically symptomatic PAD, atherosclerosis based amputation, stent implantation, angiplasty) Diabetes present for more than 1 year.

You may qualify if:

  • Patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (ACS, angina pectoris, stroke, TIA, clinically symptomatic PAD, atherosclerosis based amputation, stent implantation, angiplasty) Diabetes present for more than 1 year.

You may not qualify if:

  • patient did not signe informed consent
  • cataract
  • after cataract operation, after optical operation, after sclera injury
  • fluorescein angiograpy performed in 6 months
  • diseases affecting the eye surface( sleritis, Sjogren sy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of Medicine and Nephrological Center

Pécs, Baranya, 7624, Hungary

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusAtherosclerosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior lecturer, University of Pécs

Study Record Dates

First Submitted

September 22, 2016

First Posted

October 28, 2016

Study Start

May 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

HU(1)