UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025430
Receipt number R000029273
Scientific Title The study about evaluation of frailty in type 2 diabetic patients and effect of nutritional and daily-life guidance
Date of disclosure of the study information 2017/01/04
Last modified on 2019/07/10 12:30:00

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Basic information

Public title

The study about evaluation of frailty in type 2 diabetic patients and effect of nutritional and daily-life guidance

Acronym

Evaluation of frailty in type 2 diabetic patients

Scientific Title

The study about evaluation of frailty in type 2 diabetic patients and effect of nutritional and daily-life guidance

Scientific Title:Acronym

Evaluation of frailty in type 2 diabetic patients

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate frailty in elderly type 2 diabetic patients and examine the relationship between presence and absence of frailty and glycemic control status, and aim to verify an improving effect in frailty and blood glucose control by nutrition and daily-life guidance .

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

frailty scores at 0, 3, 6, 12 months

Key secondary outcomes

HbA1c


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

nutrition and daily-life guidance

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

65 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

type 2 diabetic patients

Key exclusion criteria

dementia
need of nursing care
hospitalization
admission for nursing home

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hisaya
Middle name
Last name Kawate

Organization

Nakamura Gakuen University

Division name

Faculty of Nutritional Sciences

Zip code

814-0198

Address

Fukuoka

TEL

0928516496

Email

kawate@nakamura-u.ac.jp


Public contact

Name of contact person

1st name Hisaya
Middle name
Last name Kawate

Organization

Nakamura Gakuen University

Division name

Faculty of Nutritional Sciences

Zip code

814-0198

Address

Fukuoka

TEL

0928516496

Homepage URL


Email

kawate@nakamura-u.ac.jp


Sponsor or person

Institute

Faculty of Nutritional Sciences, Nakamura Gakuen University

Institute

Department

Personal name



Funding Source

Organization

Nakakmura Gakuen University

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

Nakakmura Gakuen University

Address

5-7-1 Befu, Jonan-ku, Fukuoka

Tel

092-851-2531

Email

snakano@nakamura-u.ac.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

千早病院(福岡市東区)、樋口病院(福岡県春日市)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 04 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

2017 Year 01 Month 04 Day

Date of IRB

2016 Year 12 Month 26 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 27 Day

Last modified on

2019 Year 07 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029273


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name