UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026203 |
|---|---|
| Receipt number | 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 19:19:13 |
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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
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
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
Address
Tel
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
Value
https://center6.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 |
