UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031357 |
|---|---|
| Receipt number | R000035795 |
| Scientific Title | The study of risk factors on frailty and sarcopenia in elderly diabetic patients |
| Date of disclosure of the study information | 2018/02/18 |
| Last modified on | 2021/03/15 10:43:48 |
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Basic information
Public title
The study of risk factors on frailty and sarcopenia in elderly diabetic patients
Acronym
The study of frailty in elderly diabetic patients
Scientific Title
The study of risk factors on frailty and sarcopenia in elderly diabetic patients
Scientific Title:Acronym
The study of frailty in elderly diabetic patients
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to clarify risk factors on frailty and sarcopenia and to use it for treatment of elderly diabetic patients from now on.
Basic objectives2
Others
Basic objectives -Others
Currently, with the progress of aging society, elderly diabetic patients are also increasing. In our study of the risk factors correlated with frailty in elderly diabetic patients,we clarified that malnutrition and low HbA1c level contribute to the deterioration of frailty. The intervention in frailty and sarcopenia is important as part of treatment of diabetes and prevention of complications in order to increase healthy life span.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate which factors of the evaluation items such as blood DHEA-S, cortisol, cortisol / DHEAS ratio, other blood collection results, physical function, cognitive function, arteriosclerosis and osteoporosis etc are related to frailty and sarcopenia.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese elderly patients( aged 65 years or older) receiving treatment for type 2 diabetes in Muta Hospital.
Key exclusion criteria
Patients under 65 years of age or without type 2 diabetes.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hajime, Toshihiko |
| Middle name | |
| Last name | Hajime Nawata, Toshihiko Yanase |
Organization
Muta Hospital
Fukuoka University Hospital
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
814-0163
Address
3-9-1, Hoshikuma, Sawara-ku Fukuoka-shi, Fukuoka, 814-0163, Japan/ 7-45-1 Nanakuma, Jonan-ku,Fukuoka 814-0180, Japan
TEL
092-801-1011
tyanase@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Yanase |
Organization
Fukuoka University Hospital
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka 814-0180, Japan
TEL
092-801-1011
Homepage URL
tyanase@fukuoka-u.ac.jp
Sponsor or person
Institute
Muta Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University 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,Japan
Tel
092-865-2211
info@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
| 2018 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
https://academic.oup.com/jes/article/3/4/801/5368377
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/jes/article/3/4/801/5368377
Number of participants that the trial has enrolled
108
Results
Multiple regression analysis showed that the independent risk factors for sarcopenia were a serum cortisol/DHEA-S ratio >0.2, diastolic blood pressure <70 mmHg, hemoglobin concentration <13 g/dL, and an ankle brachial index <1.0. The strongest risk factor for sarcopenia was a serum cortisol/DHEA-S ratio >0.2. An increase in the serum cortisol/DHEA-S ratio reflected higher cortisol values and lower DHEA-S values in patients with sarcopenia compared with those in non-sarcopenic patients.
Results date posted
| 2019 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 108 cinsective elderly patients aged >65 years with T2DM (mean age 76.2years; 43.5% males).
Participant flow
We retrospectively reviewed the data from 108 consecutive elderly patients aged >65 years with T2DM who were being treated as outpatients or were hospitalized in Muta Hospital from October 2016 to September 2017; all 108 patients were enrolled in the present study.
Adverse events
Nothing
Outcome measures
Sarcopenia was assessed and diagnosed based on the Asian version of the diagnostic criteria regarding muscular strength, physical function, and muscle mass. We assessed various physical parameters, blood tests, and atherosclerosis markers, and statistically determined the risk factors for sarcopenia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 20 | Day |
Other
Other related information
Japanese elderly patients ( aged 65 years or older ) were selected randomly and under treatment for T2DM in Muta Hospital.
With aging, blood DHEAS decreases markedly. Recently, there is a report that the blood DHEAS is low in Frailty group. There is also a report that cortisol and cortisol / DHEAS ratio are significantly higher in the Flailty group than in the non-frailty group.It has become possible to measure the low concentration of DHEAS in the blood of the elderly by CLEIA method. In addition, considering the daily fluctuation of cortisol, blood is collected around 8-11 AM. We will measure DHEAS and cortisol at regular blood test for diabetes treatment.
By clarifying the relationship between sarcopenia, malnutrition, dementia, factors including DHEAS, cortisol and frailty in elderly diabetic patients, good intervention with frailty will be possible in the future.
Management information
Registered date
| 2018 | Year | 02 | Month | 18 | Day |
Last modified on
| 2021 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035795
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