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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027679
Receipt No. R000031676
Scientific Title The study for association between prevalence of sarcopenia and nutrition intakes and motor function in geriatric diabetes
Date of disclosure of the study information 2017/06/15
Last modified on 2019/06/10

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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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 07 Day
Last modified on
2019 Year 06 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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