UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035709 |
|---|---|
| Receipt number | R000040673 |
| Scientific Title | Prospective study on glycemic control and patient QOL for the presence of Diabetic Hand |
| Date of disclosure of the study information | 2019/01/30 |
| Last modified on | 2019/01/30 08:29:52 |
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Basic information
Public title
Prospective study on glycemic control and patient QOL for the presence of Diabetic Hand
Acronym
Prospective study on glycemic control and patient QOL for the presence of Diabetic Hand
Scientific Title
Prospective study on glycemic control and patient QOL for the presence of Diabetic Hand
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Jun Takeuchi |
Organization
Sapporo diabetes and thyroid clinic
Division name
Diabetes Medicine department
Zip code
Address
Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117071024
jun_takeuchi@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Takeuchi |
Organization
Sapporo diabetes and thyroid clinic
Division name
Diabetes Medicine department
Zip code
Address
Nishi 2, Kita 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117071024
Homepage URL
jun_takeuchi@me.com
Sponsor or person
Institute
Sapporo diabetes and thyroid clinic
Institute
Department
Personal name
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)
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040673
