UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018982
Receipt number R000021956
Scientific Title Osteo-Vascular-Lipo interactions using a variety of assessment tools in diabetes mellitus and non-diabetic patients cross-sectional study
Date of disclosure of the study information 2015/09/11
Last modified on 2015/09/14 16:47:37

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Basic information

Public title

Osteo-Vascular-Lipo interactions using a variety of assessment tools in diabetes mellitus and non-diabetic patients cross-sectional study

Acronym

Osteo-Vascular-Lipo interactions

Scientific Title

Osteo-Vascular-Lipo interactions using a variety of assessment tools in diabetes mellitus and non-diabetic patients cross-sectional study

Scientific Title:Acronym

Osteo-Vascular-Lipo interactions

Region

Japan


Condition

Condition

diabetes and non-diabetic patients

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the Osteo-Vascular-Lipo Interactions using a variety of assessment tools in diabetes mellitus and non-diabetic patients

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between bone mineral density and visceral fat, subcutaneous fat and bone marrow fat in type 1 diabetes, type 2 diabetes, and non-diabetic patients

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Subjects who treatment without drug for treatment of osteoporosis
(2)Subjects who give consent document about participation in the clinical study

Key exclusion criteria

(1) With diabetic ketoacidosis and diabetic coma
(2) With infection
(3)Has arteriosclerotic disease (myocardial infarction, stroke and so on) and history of them
(4) With arrhythmia
(5)With malignancy
(6)Patients who are unable MRI examination
(7) Considered as inadequate by the investigator

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yosuke Okada

Organization

University of Occupational and Environmental Health

Division name

First Department of Internal Medicine, School of Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan

TEL

+8100936031611

Email

y-okada@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Mori

Organization

University of Occupational and Environmental Health

Division name

First Department of Internal Medicine, School of Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan

TEL

+8100936031611

Homepage URL


Email

morihiro@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health

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


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 11 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

Enrolling by invitation

Date of protocol fixation

2014 Year 10 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ecological study
included patients who were treated at the Outpatient Department of the University of Occupational and Environmental Health Hospital between October 27 2014 and March 26 2017
Parameters bone mineral density fat glucose metabolism bone metabolism lipid metabolism hormone inflammatory cytokine


Management information

Registered date

2015 Year 09 Month 11 Day

Last modified on

2015 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021956


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name