UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035795