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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016718
Receipt No. R000019296
Scientific Title Prognosis of weight reduction by thyroid function
Date of disclosure of the study information 2015/04/20
Last modified on 2015/03/05

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Basic information
Public title Prognosis of weight reduction by thyroid function
Acronym THYDIET
Scientific Title Prognosis of weight reduction by thyroid function
Scientific Title:Acronym THYDIET
Region
Japan

Condition
Condition obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the significance of thyroid function including serum thyrotropin (TSH), free thyroxine (T4) and triiodothyronine (T3), which could preemptively predict the outcome of weight reduction. Moreover, this analysis will also assess the validity of thyroid function as a rebound predictor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum TSH, free T4, free T3, body weight (before and after six-month weight reduction regime), body fat composition (visceral fat)
Key secondary outcomes BMI,blood pressure,CAVI,total blood cell count,TP,Alb,T-Bil,D-Bil,AST,ALT,Gamma-GTP, BUN, Cr, Na, K, Cl, Ca, P, HbA1c, BS, IRI, T-Chol, HDL-C, LDL-C, TG, hsCRP, adiponectin, leptin

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.Obesity outpatients (BMI over 25)undergoing weight reduction.
2.Age: 20 years of age and older.
3.Men and women
Key exclusion criteria 1.Autoimmune thyroid disease patients undergoing treatment.
2.Patients under thyroid hormone (Levothyroxine) supplementation.
3.Patients being administered medicine which affects thyroid function, such as interferon.
4.Patients whom the chief physician determines are not applicable for the study.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Satoh-Asahara
Organization National Hospital Organization,
Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,KYOTO 612-8555
TEL 075-641-9161
Email nsato@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Satoh-Asahara
Organization National Hospital Organization, Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,KYOTO 612-8555
TEL 075-641-9161
Homepage URL
Email nsato@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization,
Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization,
Kyoto Medical Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Medical and Dental University
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 京都医療センター(京都府)、東京医科歯科大学(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 20 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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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 Three hundred obesity outpatients who meet registration criteria will be the subject of this study. Anthropometric measurements and blood tests including a thyroid function test will be performed at the time of registration and 6 months after weight reduction. The relationship between weight loss and thyroid function will be evaluated in a cross-sectional manner. The association between rebound phenomenon and thyroid function before weight reduction will also be examined.

Management information
Registered date
2015 Year 03 Month 05 Day
Last modified on
2015 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019296

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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