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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000026395 |
Receipt No. | R000030274 |
Scientific Title | Brown adipose tissue using a imaging new ultrasound technique: AINU study |
Date of disclosure of the study information | 2017/03/07 |
Last modified on | 2018/03/08 |
Basic information | ||
Public title | Brown adipose tissue using a imaging new ultrasound technique: AINU study | |
Acronym | AINU study | |
Scientific Title | Brown adipose tissue using a imaging new ultrasound technique: AINU study | |
Scientific Title:Acronym | AINU study | |
Region |
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Condition | ||
Condition | Healthy Volunteer | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To visualige human brown adipose tissue using a ultrasound technique |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Visualiging of human brown adipose tissue |
Key secondary outcomes | brown adipose tissue activity, blood flow in brown adipose tissue, thermography, vascular image, body fat, Skin temperature, blood pressure, blood glucose, insulin, triglyceride, non-esterified fatty acid, thyroid stimulating hormone, T3, T4, cortisol, leptin, ghrelin, adiponectine etc |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | 2 hour cold exposure using a standardized method. | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Age>=18
2) Subjects who received FDG-PET/CT scan 3) Be able to provide written informed consent |
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Key exclusion criteria | 1) Subjects who are judge a as unsuitable for the study by the investigator or medical doctor | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Clinical Research Institute, National Hospital Organization Kyoto Medical Center | ||||||
Division name | Division of Preventive Medicine | ||||||
Zip code | |||||||
Address | 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan | ||||||
TEL | +81-75-641-9161 | ||||||
nsakane@kyotolan.hosp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | Clinical Research Institute, National Hospital Organization Kyoto Medical Center | ||||||
Division name | Division of Preventive Medicine | ||||||
Zip code | |||||||
Address | 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan | ||||||
TEL | +81-75-641-9161 | ||||||
Homepage URL | |||||||
nsakane@kyotolan.hosp.go.jp |
Sponsor | |
Institute | Division of Preventive Medicine, Clinical Research Institute, Clinical Research Institute, National Hospital Organization Kyoto Medical Center |
Institute | |
Department |
Funding Source | |
Organization | National Hospital Organization Kyoto Medical Center |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Jyoto Orthpaedic Clinic
Hokkaido University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030274 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |