UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016718
Receipt number 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 12:58:03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

National Hospital Organization,
Kyoto Medical Center

Institute

Department

Personal name



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

Value
https://center6.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