UMIN-CTR Clinical Trial

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
Institute	Seiwakai Muta Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035340