UMIN-CTR Clinical Trial

Basic information
Public title	The study for association between prevalence of sarcopenia and nutrition intakes and motor function in geriatric diabetes
Acronym	Association between sarcopenia and nutrition intake and motor function in geriatric diabetes
Scientific Title	The study for association between prevalence of sarcopenia and nutrition intakes and motor function in geriatric diabetes
Scientific Title:Acronym	Association between sarcopenia and nutrition intake and motor function in geriatric diabetes
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety about the interventions which combined high protein diet with exercise in elderly diabetes with sarcopenia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of skeletal muscle mass and muscle strength by the 1-year intervention
Key secondary outcomes	Changes of the quality and quantity of nutrition intake and physical activity, motor function, muscle strength, blood test (HbA1c, TC, TG, HDL-C, LDL-C, nonHDL-C, Cre, BUN, eGFR, UA) by the 1-year intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Control Conventional method (nutrition, exercise)
Interventions/Control_2	Intervention 1 Intensive nutrition(energy <30kcal/kg body weight, protein <1.2g/kg body weight)
Interventions/Control_3	Intervention 2 Intensive nutrition (energy <30kcal/kg body weight, protein <1.2g/kg body weight) and exercise (resistance + aerobic exercise)
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	1. The patients with type 2 diabetes, 65 years of age and older 2. Outpatient 3. Without diabetic complications (nephropathy, retinopathy, neuropathy) 4. Not attend the other study the past 30 days
Key exclusion criteria	1. Diabetic nephropathy stage 3 or 4 2. Using steroid 3. Severe lever and/or renal dysfunction 4. Severe infection, injury, perioperative situation 5. The past of the gastrointestinal operation 6. With obvious dementia or mental disease 7. With cardiac pacemaker, implanted defibrillator 8. Considered to be inappropriate by the physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shota Middle name Last name Moyama
Organization	Kansai Electric Power Hospital
Division name	Center for Metabolism and Clinical Nutrition
Zip code	553-0003
Address	2-1-7 Fukushima, Fukushima-ku, Osaka-city, Osaka 553-0003, Japan
TEL	06-6458-5821
Email	shota0531@gmail.com

Public contact
Name of contact person	1st name Shota Middle name Last name Moyama
Organization	Kansai Electric Power Hospital
Division name	Center for Metabolism and Clinical Nutrition
Zip code	553-0003
Address	2-1-7 Fukushima, Fukushima-ku, Osaka-city, Osaka 553-0003, Japan
TEL	06-6458-5821
Homepage URL
Email	shota0531@gmail.com

Sponsor
Institute	Kansai Electric Power Medical Research Institute
Institute
Department

Funding Source
Organization	Kansai Electric Power Medical Research Institute
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	Kansai Electric Power Hospital Research Ethics Committee
Address	2-1-7 Fukushima, Fukushima-ku, Osaka-city, Osaka 553-0003, Japan
Tel	06-6458-5821
Email	koga.kazuhiro@c3.kepco.co.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	関西電力病院（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 15 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	96
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 06 Month 05 Day
Date of IRB	2017 Year 05 Month 19 Day
Anticipated trial start date	2017 Year 07 Month 03 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 11 Month 01 Day
Date trial data considered complete	2019 Year 12 Month 10 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 06 Month 07 Day
Last modified on	2020 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031676