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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030639
Receipt No. 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 2017/12/30

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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


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
Middle name
Last name Yasushi Tanaka
Organization St.Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Email smu.tainai@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shin Kawanabe
Organization St.Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email s2kawanabe@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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
2017 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.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


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