UMIN-CTR Clinical Trial

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
Email	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
Email	mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024036