UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012630 |
|---|---|
| Receipt number | R000014755 |
| Scientific Title | Health, Energy expenditure and AnThropometric indices Study |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2013/12/19 17:38:03 |
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Basic information
Public title
Health, Energy expenditure and AnThropometric indices Study
Acronym
HEAT Study
Scientific Title
Health, Energy expenditure and AnThropometric indices Study
Scientific Title:Acronym
HEAT Study
Region
| Japan |
Condition
Condition
General population
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
As hip circumference may reflect body muscle mass and peripheral subcutaneous fat, we hypothesized that preserved muscle mass is predictive for resistance to obesity-associated insulin resistance and metabolic abnormalities. In the present study, we tested this hypothesis by analyzing relationship between lean body mass and insulin resistance/metabolic abnormalities. We further determined the best body measure reflecting lean body mass.
Basic objectives2
Others
Basic objectives -Others
gene expression analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
As hip circumference may reflect body muscle mass and peripheral subcutaneous fat, we hypothesized that preserved muscle mass is predictive for resistance to obesity-associated insulin resistance and metabolic abnormalities. In the present study, we tested this hypothesis by analyzing relationship between lean body mass and insulin resistance/metabolic abnormalities.
Key secondary outcomes
We further determined the best body measure reflecting lean body mass.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent medical examination at public Matto Ishikawa Central Hospital.
Patients who underwent CT and double X-ray absorptiometry method (DEXA) within one month of medical examination
Key exclusion criteria
Patients suffering from malignant disease.
Patients with a history of cardio- vascular disease.
Pregnant or lactating women.
Investigator was deemed inappropriate as the subject of this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari Takamura |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2234
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinari Takamura |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2234
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Department of Internal Medicine, Public Central Hospital of Matto Ishikawa, Hakusan, Ishikawa, Japan,
Institute
Department
Personal name
Funding Source
Organization
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences,
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
Secondary IDs
Secondary IDs
YES
Study ID_1
887
Org. issuing International ID_1
the Ethics Committee of Kanazawa University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
石川県公立石川松任中央病院 内科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 01 | Day |
Other
Other related information
As hip circumference may reflect body muscle mass and peripheral subcutaneous fat, we hypothesized that preserved muscle mass is predictive for resistance to obesity-associated insulin resistance and metabolic abnormalities. In the present study, we tested this hypothesis by analyzing relationship between lean body mass and insulin resistance/metabolic abnormalities. We further determined the best body measure reflecting lean body mass.
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014755
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
