UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050507 |
|---|---|
| Receipt number | R000057503 |
| Scientific Title | Research on clinical characteristics of dynapenia and sarcopenia in the elderlies |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2023/03/06 17:28:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on clinical characteristics of dynapenia and sarcopenia in the elderlies
Acronym
Research on clinical characteristics of muscle weakness in the elderlies
Scientific Title
Research on clinical characteristics of dynapenia and sarcopenia in the elderlies
Scientific Title:Acronym
Research on clinical characteristics of muscle weakness in the elderlies
Region
| Japan |
Condition
Condition
dynapenia/sarcopenia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There have been reports that dynapenia is closely related to the decline in activities of daily living and death, and it has been suggested that qualitative changes in muscle independent of sarcopenia may be the pathology, but the actual character of dynapenia is still unknown. Our aim in this study to clarify risk factors and extend healthy life expectancy.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the clinical characteristics and risk factors of dynapenia and sarcopenia, and to examine their differences.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate whether there is a relationship with physical data such as height, body weight, and blood pressure, blood sample data including hemoglobin, albumin, NT-ProBNP, and HbA1c etc, bone mineral density, and the presence or absence of a history of stroke and bone fracture.
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly patients aged 65 to 95 who receive medical treatment in outclinic or by hospitalization at Muta Hospital
Key exclusion criteria
Patients who have no corresponding data under the age of 65
Target sample size
267
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Yanase |
Organization
Muta Hospital
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
814-0163
Address
3-9-1, Hoshikuma, Sawara-ku Fukuoka-shi, Fukuoka
TEL
092-801-1011
t-yanase@seiwakai-hp.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Yanase |
Organization
Muta Hospital
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
814-0163
Address
3-9-1, Hoshikuma, Sawara-ku Fukuoka-shi, Fukuoka
TEL
092-801-1011
Homepage URL
t-yanase@seiwakai-hp.jp
Sponsor or person
Institute
Muta Hospital
Institute
Department
Personal name
Funding Source
Organization
Muta Hospital
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
Muta Hospital
Address
3-9-1, Hoshikuma, Sawara-ku Fukuoka-shi, Fukuoka
Tel
092-865-2211
h-asakawa@seiwakai-muta-hp.or.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
牟田病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
267
Results
Common risk factors in dynapenia and sarcopenia groups were diabetes, previous stroke, previous fractures, lower Hb, and lower HDL-C. On the other hand, in patients with dynapenia, BMI was relatively higher than sarcopenia, and lower YAM in the femoral neck or lumbar spine corresponding to osteoporosis was observed only in sarcopenia.
Results date posted
| 2023 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From March 2015 to July 2020, 267 patients aged 65 years or older who visited the internal medicine department of our hospital were included(Age 65-95, BMI 12.9-44.1 kg/m2).
Participant flow
Grip strength, walking speed, and skeletal muscle mass were measured, and based on the 2019 AWGS diagnostic criteria, the subjects were divided into three groups.
Control; normal in muscle strength and physical function regardless of muscle mass
Dynapenia; normal in muscle mass and decrease in muscle grip and/or physical function
Sarcopenia; decrease in muscle mass, and decrease in hand grip and/or physical activity
Adverse events
Nothing
Outcome measures
The physical data of height, BW, BMI, SBP and DBP and the laboratory data including RBC count, Hb, serum blood chemistry, NTProBNP and HbA1c were also measured. Serum blood chemistry includes total protein, albumin, AST, ALT, gamma GTP, chE, BUN, creatinine, eGFR, sodium, potassium, clolide, corrected calcium, uric acid, HDLC, LDLC, and TG.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Previously, we have clarified the following:
1. The risk factors for frailty in elderly diabetic patients (old age, low Alb, low HbA1c, etc.) (JDI 9,419,2018).
2. Low levels of the anabolic hormone DHEAS, high levels of the catabolic hormone cortisol, and low levels of the DHEAS/cortisol ratio were found to be proportional to the severity of sarcopenia in elderly diabetic patient(JES3, 801, 2019).
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057503
