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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044687
Receipt No. R000050959
Scientific Title Evaluation and prevention of diabetic osteosarcopenia in the elderly by nutritional intervention and physical activity advice: DOS study ( Diabetic OsteoSarcopenia study in the elderly): an open, single-arm, prospective, interventional study.
Date of disclosure of the study information 2021/06/28
Last modified on 2021/06/29

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Basic information
Public title Evaluation and prevention of diabetic osteosarcopenia in the elderly by nutritional intervention and physical activity advice: DOS study ( Diabetic OsteoSarcopenia study in the elderly): an open, single-arm, prospective, interventional study.
Acronym DOS study
Scientific Title Evaluation and prevention of diabetic osteosarcopenia in the elderly by nutritional intervention and physical activity advice: DOS study ( Diabetic OsteoSarcopenia study in the elderly): an open, single-arm, prospective, interventional study.
Scientific Title:Acronym DOS study
Region
Japan

Condition
Condition type 2 diabetes, osteoporosis, sarcopenia
Classification by specialty
Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation and intervention of sarcopenia and osteoporosis in elderly type 2 diabetic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement rate of endpoints for sarcopenia, osteoporosis, diabetes, nutritional status, and fatty liver after nutritional guidance and physical activity advice
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 1.nutritional intervention
duration of intervention:18 months
frequency of intervention:4
2.physical activity advice
duration of intervention:18 months
frequency of intervention:4
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who received sufficient explanation, and gave their informed written consent voluntarily with sufficient understanding.
2. Patients aged 75 years old and over at the time of consent.
3. Patients diagnosed with type 2 diabetes based on diagnostic criteria or treatment history.
Key exclusion criteria (1) Patients with obvious dementia or mental illness.
(2) Patients using steroids.
(3) Patients with hepatic disorder with a Child-Pugh classification of 7 points or higher, or renal dysfunction with a serum creatinine level of 2 mg / dL or higher.
(4) Heart failure with restricted physical activity (NYHA classification II or higher).
(5) Patients with significant chronic complications of diabetes (nephrosis, active proliferative retinopathy, severe autonomic neuropathy).
(6) Patients with an infectious disease corresponding to SIRS (systemic inflammatory response syndrome) or trauma with an AIS (abbreviated injury scale) score of 4 or higher.
(7) Patients who are judged to have incurable cancer.
(8) Patients with a cardiac pacemaker or implantable cardioverter-defibrillator, etc.
(9) Patients with motor paralysis of limbs due to central nervous system disease.
(10) Patients who are judged to be inappropriate for this clinical study by the person in charge of research or the research coordinator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Suzuki
Organization Fujita Health University School of Medicine
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan.
TEL 0562-93-9242
Email aslapin@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Takayanagi
Organization Fujita Health University School of Medicine
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan.
TEL 0562-93-9242
Homepage URL
Email haratake@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Department of Endocrinology, Diabetes and Metabolism
Institute
Department

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 Fujita Health University Ethics Review Committee
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan.
Tel 0562-93-2865
Email f-irb@fujita-hu.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
2021 Year 06 Month 28 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 Open public recruiting
Date of protocol fixation
2021 Year 05 Month 14 Day
Date of IRB
2021 Year 05 Month 14 Day
Anticipated trial start date
2021 Year 06 Month 28 Day
Last follow-up date
2024 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
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050959

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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