UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019155
Receipt number R000022148
Scientific Title Association diabetic complications and finger autofluorescence
Date of disclosure of the study information 2015/09/30
Last modified on 2021/04/06 17:38:46

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Basic information

Public title

Association diabetic complications and finger autofluorescence

Acronym

Finger autofluorescence in diabetes

Scientific Title

Association diabetic complications and finger autofluorescence

Scientific Title:Acronym

Finger autofluorescence in diabetes

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether skin autofluorescene is associated with severity and prognosis of diabetic complications.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Newly onset of diabetic complications

Key secondary outcomes

Worsening diabetic complications ,Total mortality


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with diabetes,IGT,NGT

Key exclusion criteria

none

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Ogawa
Middle name
Last name Osamu

Organization

Kameda Medical Center

Division name

Department of Diabetes and Endocrinology

Zip code

296-8602

Address

929 Higashi-cho Kamogawa City

TEL

04-7092-2211

Email

ogawa.osamu@kameda.jp


Public contact

Name of contact person

1st name Ogawa
Middle name
Last name Osamu

Organization

Kameda Medical Center

Division name

Department of Diabetes and Endocrinology

Zip code

296-8602

Address

929 Higashi-cho Kamogawa City

TEL

04-7092-2211

Homepage URL


Email

ogawa.osamu@kameda.jp


Sponsor or person

Institute

Kameda Medical Center

Institute

Department

Personal name



Funding Source

Organization

Kameda Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kameda Medical Center

Address

929 Higashi-cho Kamogawa City

Tel

04-7092-2211

Email

rinri@kameda.jp


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 09 Month 30 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


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

No longer recruiting

Date of protocol fixation

2015 Year 06 Month 30 Day

Date of IRB

2015 Year 06 Month 30 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2015 Year 09 Month 29 Day

Last modified on

2021 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name