UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030639 |
|---|---|
| Receipt number | R000034984 |
| Scientific Title | Effect of resistance training and essential amino acids intake in elderly diabetes patients with sarcopenia |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2023/07/25 22:05:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of resistance training and essential amino acids intake in elderly diabetes patients with sarcopenia
Acronym
Effect of resistance training and amino acids intake in elderly diabetes patients with sarcopenia
Scientific Title
Effect of resistance training and essential amino acids intake in elderly diabetes patients with sarcopenia
Scientific Title:Acronym
Effect of resistance training and amino acids intake in elderly diabetes patients with sarcopenia
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 changes muscle strength and lean body mass with resistance training and/or essential amino acids intake in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the changes in quadriceps muscle strength before and after 1-year intervention
Key secondary outcomes
1)The change of HbA1c by the 1-year intervention.
2)The change in total body muscle mass evaluated by dual-energy x-ray absorptiometry(DEXA) by the 1-year intervention.
3)Physical activity amount evaluated by physical activity meter
4)The change in total body muscle mass evaluated by Bioelectrical Impedance Analysis (BIA)
5)The changes in bone density evaluated by DEXA and in bone metabolism markers
6)Evaluation of mood change using GDS, SF36v2
7)Comparison of differences in quadriceps muscle strength between the elastics training groups and control groups
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
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment | Behavior,custom |
Interventions/Control_1
Control
Conventional method
Interventions/Control_2
Intervention 1
Resistance exercise using rubber tube for 20 to 30 minutes a day.
Interventions/Control_3
Intervention 2
Resistance exercise using rubber tube for 20 to 30 minutes a day and take essential amino acids per day.
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
| 70 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with type 2 diabetes
2) over 70 and under 80 years old
3) Patient suspected of Sarcopenia
4) Patients without cognitive dysfunction (MMSE score of 24 or more)
5) Patients who are capable of making a decision by themselves, and provide written cosent.
Key exclusion criteria
1) Patients with type 2 diabetes
2) Patients without cognitive dysfunction (MMSE 23 points or less)
3) Patients who should ban or limit exercise therapy.Severe ketosis and fasting blood glucose 250 mg or more.Fresh ocular bleeding due to proliferative retinopathy.Severe renal dysfunction.Ischemic heart disease and disorder of cardiopulmonary.Bone and joint disease.Severe infection.Diabetic gangrene.Advanced diabetes autonomic disorder.
4)Patients who are receiving the following diabetes drugs.
SGLT2 inhibitor, Pioglitazone, GLP-1 receptor agonist.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Tanaka |
Organization
St.Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
smu.tainai@gmail.com
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kawanabe |
Organization
St.Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
s2kawanabe@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2019 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 12 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034984
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
