UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030945
Receipt number R000035340
Scientific Title Intervention study on flail and sarcopenia of elderly diabetic patients
Date of disclosure of the study information 2018/02/01
Last modified on 2019/07/26 13:35:22

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Basic information

Public title

Intervention study on flail and sarcopenia of elderly diabetic patients

Acronym

Research on rehabilitation nutrition for elderly diabetes

Scientific Title

Intervention study on flail and sarcopenia of elderly diabetic patients

Scientific Title:Acronym

Research on rehabilitation nutrition for elderly diabetes

Region

Japan


Condition

Condition

Frail and sarcopenia in diabetic patients

Classification by specialty

Medicine in general Endocrinology and Metabolism Geriatrics
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine how nutritional intake and exercise therapy as an intervention in frail and sarcopenia affects the frail risk factor of elderly diabetic patients, furthermore to clarify the relation factors between those effects and clinical valuables.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical Fraility Scale, Sarcopenia Evaluation factors(Grip strength, walking speed, muscle mass),Intervention period:3 months

Key secondary outcomes

blood test (blood collection within the general diagnostic range such as HbA1c value and blood sugar level, high sensitivity CRP, 25 (OH) vitamin D, prealbumin, DHEAS, Zn, Cu), urinalysis items (general medical items, urinary albumin), nutrition survey, MNA-SF, MMSE, Vitality Index, GDS 15, medical records.There is possibility to add or refer to noninvasive inspection items other than the above.


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

Diabetic nephropathy 1st, 2nd, 3rd: Meibalance Reha Support Mini (Meiji)
Diabetic nephropathy 4th: Aminocare jelly leucine 40 (Nestle Health Science)
Consume the above one everyday, in addition to exercise therapy twice a week

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Diabetes patients over 65 years old who are visiting Muta Hospital

Key exclusion criteria

1: Those who are allergic to allergic indication components of nutritional supplements used in this study
2: Those who are extremely poor in general condition or those who are not permitted to exercise therapy from their doctor
3: Those who do not agree with this research
4: Persons who can not measure body composition with an inbody770 due to difficulty holding upright position

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuya Fujihara

Organization

Seiwakai Muta Hospital

Division name

Internal medicine,Department of Diabetes Medicine

Zip code


Address

3-9-1, Hoshikuma, Sawara-ku, Fukuoka city,Fukuoka

TEL

092-865-2211

Email

y-fujihara@seiwakai-muta-hp.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuya Fujihara

Organization

Seiwakai Muta Hospital

Division name

Internal medicine,Department of Diabetes Medicine

Zip code


Address

3-9-1, Hoshikuma, Sawara-ku, Fukuoka city,Fukuoka

TEL

092-865-2211

Homepage URL


Email

y-fujihara@seiwakai-muta-hp.or.jp


Sponsor or person

Institute

Seiwakai Muta Hospital

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd., Nestle HealthScience Co., Ltd., Siemens Healthcare Diagnostics K.K.

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

2018 Year 02 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

Completed

Date of protocol fixation

2017 Year 11 Month 13 Day

Date of IRB

2017 Year 11 Month 13 Day

Anticipated trial start date

2018 Year 02 Month 07 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 23 Day

Last modified on

2019 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name