UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The balance ability in patients with Type 2 diabetes correlates closely with the progression of diabetic complications.
Title of the study (Brief title)	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	Eiichi Araki
Organization	Kumamoto University, Faculty of Life Sciences
Division name	Metabolic Medicine
Address	1-1-1 HONJO, CHUO, Kumamoto
TEL	+81963735169
Email	earaki@kumamoto-u.ac.jp

Public contact
Name of contact person	Daisuke Kukidome
Organization	Kumamoto University Hospital
Division name	Metabolic Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010224