UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019729
Receipt number R000022786
Scientific Title Exploratory research of Expression of Acrolein and Vascular Adhesion Protein-1 (VAP-1) in Diabetic Retinopathy
Date of disclosure of the study information 2015/11/10
Last modified on 2016/11/11 15:51:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Exploratory research of Expression of Acrolein and Vascular Adhesion Protein-1 (VAP-1) in Diabetic Retinopathy

Acronym

Acrolein and VAP-1 in Diabetic Retinopathy

Scientific Title

Exploratory research of Expression of Acrolein and Vascular Adhesion Protein-1 (VAP-1) in Diabetic Retinopathy

Scientific Title:Acronym

Acrolein and VAP-1 in Diabetic Retinopathy

Region

Japan


Condition

Condition

Diabetic Retinopathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure the concentrations of acrolein and VAP-1 in the vitreous and serum samples obtained from patients with diabetic retinopathy

Basic objectives2

Others

Basic objectives -Others

To investigate the relationship between acrolein and VAP-1 in diabetic retinopathy

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concentrations of acrolein and soluble VAP-1 in the vitreous and serum samples obtained from patients with diabetic retinopathy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients with proliferative diabetic retinopathy (Study group)
2. Patients with idiopathic macular hole or epiretinal membrane (Control group)
3.Patients who had a detailed briefing of the study with explanatory documents prior to the enrollment and voluntarily signed a consent form

Key exclusion criteria

1. Patients with vitreous hemorrhage due to proliferative diabetic retinopathy
2. Patients with diabetes in control group
3.Patients who investigator considered inappropriate as a subject of this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kousuke Noda

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

N-15, W-7, Kita-ku, Sapporo

TEL

011-706-5944

Email

nodako@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kousuke Noda

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

N-15, W-7, Kita-ku, Sapporo

TEL

011-706-5944

Homepage URL


Email

nodako@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Hokkaido University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The present data show that 1) the levels of acrolein-conjugated protein and VAP-1/SSAO increase in the vitreous fluid of patients with diabetic retinopathy and 2) there is moderate positive correlation between acrolein-conjugated protein and VAP-1/SSAO.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A prospective observational study.
Vitreous samples will be collected from patients with proliferative diabetic retinopathy and non-diabetic ocular diseases, i.e., epiretinal membrane (ERM) and idiopathic macular hole (MH), who underwent pars plana vitrectomy in Hokkaido University Hospital from 2015/11 to 2016/3.
The amounts of acrolein-conjugated protein, VAP-1/SSAO, oxidative stress marker, and enzymatic activity of VAP-1/SSAO will be evaluated.


Management information

Registered date

2015 Year 11 Month 10 Day

Last modified on

2016 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name