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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name