UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044687 |
|---|---|
| Receipt number | 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 | 2024/02/17 19:17:12 |
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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
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
haratake@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Department of Endocrinology, Diabetes and Metabolism
Institute
Department
Personal name
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
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
| 2026 | 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
| 2024 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050959
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
