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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031357
Receipt No. 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 2020/01/09

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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
Email 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
Email tyanase@fukuoka-u.ac.jp

Sponsor
Institute Muta Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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