UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014977
Receipt number R000014787
Scientific Title Evaluation of annual fluctuation of HbA1c of diabetes patients.
Date of disclosure of the study information 2014/08/28
Last modified on 2018/08/31 10:59:31

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Basic information

Public title

Evaluation of annual fluctuation of HbA1c of diabetes patients.

Acronym

Evaluation of annual fluctuation of HbA1c of diabetes patients.

Scientific Title

Evaluation of annual fluctuation of HbA1c of diabetes patients.

Scientific Title:Acronym

Evaluation of annual fluctuation of HbA1c of diabetes patients.

Region

Japan


Condition

Condition

type 2 diabetes mellitus (T2DM)

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We study the effect of the dietary intervention on the annual fluctuation of HbA1c of the type 2 diabetic patients as retrospective study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We divide T2DM patients into two groups, the dietary interventioned group and the non-dietary interventioned group, and compare the fluctuation of HbA1c.

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Outpatient with T2DM

Key exclusion criteria

Shedding of ambulatory

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taishi Aosa

Organization

Inobe Hospital

Division name

Office of Nutrition

Zip code


Address

255, Nakao, Oita, OITA

TEL

097-586-5522

Email

m12d9002@oita-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taishi Aosa

Organization

Inobe Hospital

Division name

Office of Nutrition

Zip code


Address

255, Nakao, Oita, OITA

TEL

097-586-5522

Homepage URL


Email

m12d9002@oita-u.ac.jp


Sponsor or person

Institute

Inobe hospital

Institute

Department

Personal name



Funding Source

Organization

Inobe Hospital

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

2014 Year 08 Month 28 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

Completed

Date of protocol fixation

2013 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information

We finished the study.


Management information

Registered date

2014 Year 08 Month 28 Day

Last modified on

2018 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014787


Research Plan
Registered date File name
2018/08/31 臨床試験登録.pdf

Research case data specifications
Registered date File name
2018/08/31 臨床試験登録.pdf

Research case data
Registered date File name
2018/08/31 臨床試験登録.pdf