UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020901 |
|---|---|
| Receipt number | R000024036 |
| Scientific Title | Clinical research on the risk factors of Sarcopenia in diabetic patients |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2022/02/01 09:28:01 |
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Basic information
Public title
Clinical research on the risk factors of Sarcopenia in diabetic patients
Acronym
Impact of diabetes mellitus on dynapenia study(iDIAMOND study)
Scientific Title
Clinical research on the risk factors of Sarcopenia in diabetic patients
Scientific Title:Acronym
Impact of diabetes mellitus on dynapenia study(iDIAMOND study)
Region
| Japan |
Condition
Condition
Diabetes, Sarcopenia, Dynapenia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this cross-sectional and longitudinal research is to reveal the impacted risk factor(AGE, IGF-1, testosterone) on sarcopenia and dynapenia with patient diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between skin autofluorescence, IGF-1, testosteron and limb skeletal muscle mass and knee extension strength(measurement of once a year).
Key secondary outcomes
The relationship between sarcopenia biomarker and age and diabetes factor(measurement of once a year).
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 1 and 2 Diabetes , non-diabetic, community-dwelling older
Key exclusion criteria
Patients with advanced cardiovascular, cerebrovascular and kindney disease.
Patients receiving steroid treatment.
Patients with gait dysfunction.
Those for other reasons, who are decided as inadequate for subjects by their physician.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Munehide |
| Middle name | |
| Last name | Matsuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center
Zip code
770-8503
Address
3-8-15 Kuramoto-cho, Tokushima-city 770-8503
TEL
0886337587
matuhisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mori |
| Middle name | |
| Last name | Hiroyasu |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center
Zip code
770-8503
Address
3-8-15 Kuramoto-cho, Tokushima-city 770-8503
TEL
0886337587
Homepage URL
mori.hiroyasu@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University Hospital of Tokushima
Address
tokusima,kuramoto 2-50-1
Tel
088-633-9294
awachiken@tokushima-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
徳島大学病院内分泌代謝内科学（徳島県）
大阪警察病院 糖尿病・内分泌内科（大阪府）
大阪府立急性期総合医療センター 糖尿病内分泌内科（大阪府）
関西労災病院 糖尿病内分泌内科（兵庫県）
大阪労災病院 健康診断部（大阪府）
大阪回生病院 糖尿病内分泌内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jdi.13436
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jdi.13436
Number of participants that the trial has enrolled
1328
Results
Sarcopenia and dynapenia were more frequent in patients with type 1 diabetes and type 2 diabetes than in individuals without diabetes, which might contribute to their impaired quality of life and incidental falls.
Results date posted
| 2022 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This cross-sectional study enrolled 1,328 participants with type 1 diabetes (n = 177), type 2 diabetes (n = 645) and without diabetes (n = 506).
Participant flow
This was a multi-institutional joint cross-sectional study of seven medical centers on the Impact of Diabetes Mellitus on Dynapenia (iDIAMOND) Study. We recruited individuals without diabetes from the community in the Harima region.
Adverse events
None
Outcome measures
Sarcopenia was defined as a low grip strength and slow gait speed with low skeletal muscle mass index, whereas dynapenia was defined as low strengths of grip and knee extension with a normal skeletal muscle mass index. Participants without sarcopenia and dynapenia were defined as robust.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 09 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who conseto to from 1 January 2016 until 31 March 2019.
Management information
Registered date
| 2016 | Year | 02 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024036
