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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027613
Receipt No. R000031643
Scientific Title Effects of replacement therapy on indices of atherosclerosis in subclinical hypothyroidism
Date of disclosure of the study information 2017/06/02
Last modified on 2017/06/02

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Basic information
Public title Effects of replacement therapy on indices of atherosclerosis in subclinical hypothyroidism
Acronym Effects of replacement therapy on indices of atherosclerosis in subclinical hypothyroidism
Scientific Title Effects of replacement therapy on indices of atherosclerosis in subclinical hypothyroidism
Scientific Title:Acronym Effects of replacement therapy on indices of atherosclerosis in subclinical hypothyroidism
Region
Japan

Condition
Condition subclinical hypothyroidism
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of replacement therapy on indices of atherosclerosis in subclinical hypothyroidism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement of indices of atherosclerosis for 3 years
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 levothyroxine treatment
Interventions/Control_2 no medication
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 patients with subclinical hypothyroidism
Key exclusion criteria 1. patients with diabetes mellitus
2. patients with chronic kidney disease group 4 and greater
3. patients with moderate or severe liver dysfunction
4. patients with past history of myocardial infacrction, stroke, or Arteriosclerosis obliterans
5. pregnant women or women who are possibly pregnant
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Ichihara
Organization Tokyo Women's Medical University
Division name Department of Internal Medicine II, Endocrinogloy and Hypertension
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email atzichi@endm.twmu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Satoshi Morimoto
Organization Tokyo Women's Medical University
Division name Department of Internal Medicine II, Endocrinogloy and Hypertension
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email smorimoto@endm.twmu.ac.jp

Sponsor
Institute Department of Internal Medicine II, Endocrinogloy and Hypertension, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Department of Internal Medicine II, Endocrinogloy and Hypertension, Tokyo Women's Medical University
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
2017 Year 06 Month 02 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
2017 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 02 Day
Last modified on
2017 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031643

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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