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 |
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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
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
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
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
