UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021124 |
|---|---|
| Receipt number | R000024366 |
| Scientific Title | Examination of the association between AGEs and bone metabolism in type 2 diabetes patients. |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2023/03/01 14:49:13 |
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Basic information
Public title
Examination of the association between AGEs and bone metabolism in type 2 diabetes patients.
Acronym
Examination of the association between AGEs and bone metabolism in type 2 diabetes patients.
Scientific Title
Examination of the association between AGEs and bone metabolism in type 2 diabetes patients.
Scientific Title:Acronym
Examination of the association between AGEs and bone metabolism in type 2 diabetes patients.
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether skin autofluorescence is useful for assessing bone quality and fracture risk.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between skin autofluorescence and Osteoporosis
Key secondary outcomes
Patient characteristics,various parameters(Urinalysis,blood test,physiological function test),diet questionnaires and sleep questionnaires
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with type 2 diabetes
2)Age is over 20
3) Having provided voluntary written consent for participation in this study.
Key exclusion criteria
1)Patients with severe neuropathy.
2)Patients who have administered drugs influencing osteoporosis.
3)Patients who have had total gastrectomy.
4)Secondary osteoporosis excluding diabetes
5)Dialysis patient
6)Patients having bad sunburn
7)alcohol dependent patients
8)Patients who have administered supplements of Vitamin D and calcium
9)Patients with severe ketosis or diabetic coma.
10)Patients with severe infections or severe trauma.
11)Patients who are judged by an investigator to be inappropriate for this study for any other reason
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of endocrinology & metabolism
Zip code
232-0024
Address
4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL
045-261-5656
yamakat@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ichikawa |
Organization
Yokohama City University Medical Center
Division name
Department of endocrinology & metabolism
Zip code
232-0024
Address
4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL
045-261-5656
Homepage URL
t196009c@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
0453707627
rinri@yokohama-cu.ac.jp
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
横浜市立大学附属市民総合医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine whether skin autofluorescence is useful for assessing bone quality and fracture risk.
Management information
Registered date
| 2016 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024366
