UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026203
Receipt No. R000030092
Scientific Title The study of frailty risk factors in elderly diabetic patients
Date of disclosure of the study information 2017/02/17
Last modified on 2018/02/18

* 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 The study of frailty risk factors in elderly diabetic patients
Acronym The study of frailty risk factors in elderly diabetic patients
Scientific Title The study of frailty risk factors in elderly diabetic patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Hajime Nawata, Toshihiko Yanase
Organization Muta Hospital
Fukuoka University Hospital
Division name Department of Endocrinology and Diabetes Mellitus
Zip code
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
Middle name
Last name Toshihiko Yanase
Organization Fukuoka University Hospital
Division name Department of Endocrinology and Diabetes Mellitus
Zip code
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
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/jdi.12698/full
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.