UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054687 |
|---|---|
| Receipt number | R000062261 |
| Scientific Title | Relationship between protein intake estimated from 24-hour urine collection method and sarcopenia index in elderly patients with type 2 diabetes |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2025/02/04 15:12:24 |
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Basic information
Public title
Relationship between protein intake estimated from 24-hour urine collection method and sarcopenia index in elderly patients with type 2 diabetes
Acronym
Relationship between protein intake estimated from 24-hour urine collection method and sarcopenia index in elderly patients with type 2 diabetes
Scientific Title
Relationship between protein intake estimated from 24-hour urine collection method and sarcopenia index in elderly patients with type 2 diabetes
Scientific Title:Acronym
Relationship between protein intake estimated from 24-hour urine collection method and sarcopenia index in elderly patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes, Sarcopenia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the estimated protein intake based on the 24-hour urine collection method in patients with type 2 diabetes over 65 years of age and to assess its association with sarcopenia indices.
Basic objectives2
Others
Basic objectives -Others
To Identify factors causing discrepancies between estimated protein intake based on the 24-hour urine collection method and the results of the diet history questionnaire (brief-type self-administered diet history questionnaire: BDHQ)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated protein intake based on the 24-hour urine collection method
Key secondary outcomes
Baseline characteristics, blood test, skeletal muscle mass, hand grip strength, sit to stand-five test, ten item personality inventory-Japanese version (TIPI-J), treatment Self-Regulation Questionnaire-Japanese version (TSRQ-J), mini-mental state examination (MMSE), international physical activity questionnaire (IPAQ)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Those who are 65 years of age or older
2. Those who have received an explanation of the study and have given their consent to participate in the study
Key exclusion criteria
1. diabetes other than type 2 diabetes
2. eGFR <30 ml/min/1.73m2
3. Those who are on a protein-restricted diet
4. Those who undergo treatment for malignant tumors
5. Those who receive corticosteroids or anabolic steroids
6. Those who receive growth hormone
7. Those who have participated in the previous randomized controlled trial evaluating the efficacy of branched-chain amino acids and soy protein at the University of Tsukuba Hospital.
8. Those who are determined to be inappropriate to participate in this study by the Principal Investigator or a Research Associate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Matsuda |
Organization
University of Tsukuba Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba
TEL
029-853-3053
matsuda.takaaki.dd@ms.hosp.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Matsuda |
Organization
University of Tsukuba Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3053
Homepage URL
matsuda.takaaki.dd@ms.hosp.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Metabolism and Clinical Nutrition
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
Clinical research ethics committee of the University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
matsuda.takaaki.dd@ms.hosp.tsukuba.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate estimated protein intake based on the 24-hour urine collection method in people with type 2 diabetes aged 65 years and over.
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062261
