UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027679 |
|---|---|
| Receipt number | 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 | 2020/12/09 20:36:59 |
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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
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
shota0531@gmail.com
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031676
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| Registered date | File name |
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