UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051128 |
|---|---|
| Receipt number | R000058293 |
| Scientific Title | Development of nutritional therapy that contributes to the maintenance and improvement of ADL in older adults with diabetes |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/11/24 11:00:48 |
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Basic information
Public title
Nutritional intervention study to maintain and improve ADL in older adults with diabetes
Acronym
Protein enrichment intervention trial for older adults with diabetes
Scientific Title
Development of nutritional therapy that contributes to the maintenance and improvement of ADL in older adults with diabetes
Scientific Title:Acronym
Protein enrichment intervention trial for older adults with diabetes
Region
| Japan |
Condition
Condition
Diabetes, Sarcopenia
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an effective and practical nutritional therapy focusing on the maintenance and improvement of ADL in older adults with diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in muscle mass, grip strength, and breakfast protein intake ratio over 6 months.
Key secondary outcomes
Changes in stratum corneum water content, physical activity, and blood biochemical tests (HbA1c, creatinine, estimated glomerular filtration rate) over a 6 months.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Implement nutritional dietary guidance on protein intake. Specifically, protein-enriched food (commercially available) will be provided, and the daily protein intake will be 1.5 g or more per 1 kg of body weight per day, and will be intervened to eat protein 3 meals a day evenly.
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
(1) Diabetic patients aged 65 and over
(2) Subjects with decreased muscle mass or grip strength
(SMI: men <7.0 kg/m^2, women <5.7 kg/m^2, grip strength: men <28 kg, women <18 kg)
(3) Subjects whose protein intake is less than 1.2g/kg/day
(4) Patients who are outpatients
(5) Persons who can write dietary records
Key exclusion criteria
(1) Subjects with obvious dementia or mental illness
(2) Persons using steroids
(3) Patients with liver disorder with Child Pugh classification of 7 points or more, or renal dysfunction with eGFR less than 45
(4) Heart failure with limitation of physical activity (New York Heart Association classification of heart failure II or higher)
(5) Subjects who have a history of gastrointestinal reconstructive surgery
(6) Subjects who have incurable cancer
(7) Those who have a cardiac pacemaker or an implanted cardioverter-defibrillator
(8) Subjects with motor paralysis in the extremities due to central neuromuscular disease
(9) Persons who are judged to be inappropriate for this clinical study by the research implementation supervisor or co-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Moyama |
Organization
Kansai Electric Power Medical Research Institute
Division name
Department of Metabolism and Nutrition, Diabetes Research Center
Zip code
5530003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
+81-6-6458-5821
shota0531@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Moyama |
Organization
Kansai Electric Power Medical Research Institute
Division name
Department of Metabolism and Nutrition, Diabetes Research Center
Zip code
5530003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL
+81-6-6458-5821
Homepage URL
shota0531@gmail.com
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
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, Japan
Tel
+81-6-6458-5821
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
| 2023 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058293
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
