UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of frailty risk factors in elderly diabetic patients
Title of the study (Brief title)	The study of frailty risk factors in elderly diabetic patients
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Endocrinology and Metabolism Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluation of risk factors
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The stages of frailty using Clinical Frailty Scale (first examination and after 6 months)
Key secondary outcomes	The data of age, blood test, body weight, BMI, blood pressure, medication

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 diabetic patients
Key exclusion criteria	No spacial mention
Target sample size	132

Research contact person
Name of lead principal investigator	Hajime Nawata, Toshihiko Yanase
Organization	Muta Hospital Fukuoka University Hospital
Division name	Department of Endocrinology and Diabetes Mellitus
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	Toshihiko Yanase
Organization	Fukuoka University Hospital
Division name	Department of Endocrinology and Diabetes Mellitus
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)

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）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/jdi.12698/full
Results	Multiple regression analysis showed that an increase in age, low levels of albumin, high-density lipoprotein cholesterol, systolic blood pressure, HbA1c, total cholesterol, and bodyweight were statistically significant and strong independent risk factors for frailty, suggesting that reverse metabolism owing to malnutrition in elderly type 2 diabetes mellitus patients might be involved.
Other related information	Japanese elderly patients ( aged 65 years or older ) were selected randomly and under treatment for T2DM in Muta Hospital. The data for age, blood tests, general physical measurements and drugs were obtained from the medical records. In addition, follow-up data was obtained 6 months after the first examination. No intervention was made during these 6 months.

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2018 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030092