UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study on glycemic control and patient QOL for the presence of Diabetic Hand
Title of the study (Brief title)	Prospective study on glycemic control and patient QOL for the presence of Diabetic Hand
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the prevalence of diabetic hands crossingly and continuously. Analyze the relationship between the existence of Diabetic Hand and hand functions and QOL. Investigate how much the patient is inconvenienced by the existence of Diabetic Hand. Investigate the relationship between diabetic hand and the background of diabetes patients (age, gender, duration of disease, glucose tolerance, complications, treatment, etc.) Analysis of factors involved in the development of Diabetic Hand
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between Diabetic Hand and glycemic control
Key secondary outcomes	Diabetic Hand and patient QOL (EQ-5D) Diabetic Hand and Patient ADL (Hand 10) Morbidity rate of Diabetic Hand and other diabetic complications Morbidity rate of Diabetic Hand and Diabetic Foot Relationship between Diabetic Hand and patient background

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients in our hospital visit at the diagnosis of diabetes mellitus Patients who refuse to participate in this study
Key exclusion criteria	Patients who refuse to participate in this study Patient who is difficult to answer with Japanese questionnaire
Target sample size	500

Research contact person
Name of lead principal investigator	Jun Takeuchi
Organization	Sapporo diabetes and thyroid clinic
Division name	Diabetes Medicine department
Address	Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	0117071024
Email	jun_takeuchi@me.com

Public contact
Name of contact person	Jun Takeuchi
Organization	Sapporo diabetes and thyroid clinic
Division name	Diabetes Medicine department
Address	Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	0117071024
Homepage URL
Email	jun_takeuchi@me.com

Sponsor
Institute	Sapporo diabetes and thyroid clinic
Institute
Department

Funding Source
Organization	Sapporo diabetes and thyroid clinic
Organization
Division
Category of Funding Organization	Other
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	さっぽろ糖尿病・甲状腺クリニック

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 17 Day
Anticipated trial start date	2019 Year 01 Month 30 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	Unpublished
URL releasing results
Results
Other related information	Background information (at case entry): age, sex, medical history, diagnosis name, history of complications, treatment history, questionnaire created by our hospital Patient ADL, QOL survey (once a year): HAND 10 (ADL evaluation), EQ - 5 D (QOL evaluation) Scientific findings (once a year): Hand examination findings, foot examination findings, neurological findings Blood test (at least once a year): glucose tolerance test, lipid metabolism, liver function, kidney function, electrolyte Urinalysis (once a year or more): general urinalysis, albumin, protein, creatinine Physiological examination (once a year): electrocardiogram, ABI / PWV, carotid echo, bone density measurement Other (when necessary for diagnosis): nerve conduction velocity test, blood test (CRP, rheumatoid factor, CCP antibody, sperm separation test), finger joint ultrasonic examination, finger joint MRI examination, finger x-ray inspection

Management information
Registered date	2019 Year 01 Month 29 Day
Last modified on	2019 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040673