UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047180 |
|---|---|
| Receipt number | R000051016 |
| Scientific Title | Assessment of optimal protein dosage for maintaining and synthesizing muscle volume in inpatients with type 2 diabetes: Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/03/16 |
| Last modified on | 2024/05/18 14:44:40 |
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Basic information
Public title
Assessment of optimal protein dosage for maintaining and synthesizing muscle volume in inpatients with type 2 diabetes: Randomized Controlled Trial
Acronym
The optimal protein intake for patients in type 2 diabetes educational admission
Scientific Title
Assessment of optimal protein dosage for maintaining and synthesizing muscle volume in inpatients with type 2 diabetes: Randomized Controlled Trial
Scientific Title:Acronym
The optimal protein intake for patients in type 2 diabetes educational admission
Region
| Japan |
Condition
Condition
patients with type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Current guidelines is ambiguous about optimal protein doses for patients with type 2 diabetes. Hence, to assess the optimal protein doses that brings current body weight closer to ideal body weight and maintains or increases muscle volume.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle volume increasing ratio between the two groups:
High dose group; protein dose of 1.3 g / ideal body weight (kg) or more vs.
Low dose group; protein dose of less than 1.3 g / ideal body weight (kg)
Key secondary outcomes
Divide the protein dose into ~ 0.9 / 1.0 / 1.1 / 1.2 / 1.3 / 1.4 / 1.5g / kg ~ to determine at which dose muscle volume changes from loss to increase.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
protein supplementation group
Interventions/Control_2
normal diet group
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
| 20 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
.
Key exclusion criteria
.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Chinatsu |
| Middle name | |
| Last name | Yamagami |
Organization
Kyushu Nutrition Welfare University
Division name
Nutrition
Zip code
803-8511
Address
5-1-1 Shimoitozu, Kokurakita, Kitakyushu, JAPAN
TEL
+81-93-561-2136
kishitani.hatahata@gmail.com
Public contact
Name of contact person
| 1st name | Chinatsu |
| Middle name | |
| Last name | Yamagami |
Organization
Kyushu Nutrition Welfare University
Division name
Nutrition
Zip code
803-8511
Address
5-1-1 Shimoitozu, Kokurakita, Kitakyushu, JAPAN
TEL
+81-93-561-2136
Homepage URL
kishitani.hatahata@gmail.com
Sponsor or person
Institute
Kyushu Nutrition Welfare University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Nutrition Welfare University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shin Komonji Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shin Komonji Hospital
Address
2-5 Dairishinmachi, Mojiku, Kitakyushu, JAPAN
Tel
+81-93-391-1001
kishitani.hatahata@gmail.com
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
新小文字病院 (福岡県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
not exist
Publication of results
Unpublished
Result
URL related to results and publications
nothing
Number of participants that the trial has enrolled
54
Results
Significant muscle mass gain was observed in the protein group.
Results date posted
| 2024 | Year | 05 | Month | 18 | Day |
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
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051016
