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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008698
Receipt No. R000010224
Scientific Title The balance ability in patients with Type 2 diabetes correlates closely with the progression of diabetic complications.
Date of disclosure of the study information 2012/08/16
Last modified on 2017/02/22

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Basic information
Public title The balance ability in patients with Type 2 diabetes correlates closely with the progression of diabetic complications.
Acronym The balance ability in patients with Type 2 diabetes correlates closely with the progression of diabetic complications.
Scientific Title The balance ability in patients with Type 2 diabetes correlates closely with the progression of diabetic complications.
Scientific Title:Acronym The balance ability in patients with Type 2 diabetes correlates closely with the progression of diabetic complications.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigated the balance ability in patients with type 2 diabetes mellitus (T2DM) and analyzed the association between the balance ability and diabetic complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, Duration of Diabetes
Stage of Diabetic retinopathy, nephropathy, neuropathy
One-legged Timed Balance with the eyes opened, Functional Reach test
Examination for sence of pain
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 1 or type 2 diabetes mellitus and non-diabetes mellitus.
Definition of non-diabetic patients, persons who meet the less than 126mg/dL of fasting blood glucose levels and less than 6.5% of HbA1c (NGSP).
Key exclusion criteria Who were not diagnosed as suffering disease which disrupts the balance ability.
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Kumamoto University, Faculty of Life Sciences
Division name Metabolic Medicine
Zip code
Address 1-1-1 HONJO, CHUO, Kumamoto
TEL +81963735169
Email earaki@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Kukidome
Organization Kumamoto University Hospital
Division name Metabolic Medicine
Zip code
Address 1-1-1 HONJO, CHUO, Kumamoto
TEL +81963735169
Homepage URL
Email kukidome@kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University, Faculty of Life Sciences, Metabolic Medicine
Institute
Department

Funding Source
Organization Manpei Suzuki Diabetes Foundation
Japan Diabetes Foundation
Japan Association for Diabetes Education and Care
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization japan

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 熊本大学医学部附属病院(熊本県)、菊池郡市医師会立病院(熊本県)、国保水俣総合医療センター(熊本県)、くまもと成仁病院(熊本県)、聖ヶ塔病院(熊本県)

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2011 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 13 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2017 Year 09 Month 30 Day

Other
Other related information In Japan, the number of patients who were bedridden or unable to care for themselves due to falls has increased. Furthermore, there are several reports that diabetic patients are easy to stumble and fall.

Management information
Registered date
2012 Year 08 Month 16 Day
Last modified on
2017 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010224

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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