UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039730
Receipt number R000045312
Scientific Title Generation of App supporting medical nutrition therapy for elderly adults with life-style related diseases and multiple co-morbidities
Date of disclosure of the study information 2020/04/01
Last modified on 2020/09/06 09:49:07

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Basic information

Public title

Generation of App supporting medical nutrition therapy for elderly adults with life-style related diseases and multiple co-morbidities

Acronym

Generation of App supporting medical nutrition therapy for elderly adults

Scientific Title

Generation of App supporting medical nutrition therapy for elderly adults with life-style related diseases and multiple co-morbidities

Scientific Title:Acronym

Generation of App supporting medical nutrition therapy for elderly adults

Region

Japan


Condition

Condition

Diabetes, Chronic kidney disease and sarcopenia

Classification by specialty

Endocrinology and Metabolism Nephrology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To generate App supporting medical nutritional therapy for elderly adults with lifestyle-related diseases and multiple co-morbidities

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Efficacy of medical nutritional therapy o HbA1c, CKD stage and sarcopenia in 1 year.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Medical nutritional therapy

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

110 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients who have fully informed of the contents of this study using the prescribed consent documents and other explanatory consent document and who voluntarily agree to participate in this stydy.
2. Patients aged equal to or above 65 years old at the time of informed consent.
3. Patients with diabetes mellitus or chronic kidney disease (CKD).
1) Diabetes mellitus should be diagnosed according to the guideline by Japan Diabetes Society
2) CKD should be classified as G3 or above according to the guideline 2018 by Japanese Society of Nephrology

Key exclusion criteria

1. Patients with persistent hemodialysis
2. Patients with severe cognitive disorder
3. Patients with long-term immobility
4. Patients with active comorbities which could affect the results of this study
5. Patients whose doctor judges that this study is inappropriate for participation

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Suzuki

Organization

Fujita Health University

Division name

Department of Endocrinology and Metabolism

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562939242

Email

aslapin@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Suzuki

Organization

Fujita Health University

Division name

Department of Endocrinology and Metabolism

Zip code

4701192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562939242

Homepage URL


Email

aslapin@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Society of Metabolism and Clinical Nutrition

Address

3-13-11, Yotsuya, Shinjuku, Tokyo 160-0004, Japan

Tel

03-5363-2361

Email

info@jsmcn.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

2020 Year 04 Month 01 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

Open public recruiting

Date of protocol fixation

2020 Year 01 Month 03 Day

Date of IRB

2020 Year 02 Month 10 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 07 Day

Last modified on

2020 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name