UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015774 |
|---|---|
| Receipt number | R000018355 |
| Scientific Title | Associations of non-exercise activity thermogenesis with metabolic parameters in patients with glucose intolerance and type 2 diabetes |
| Date of disclosure of the study information | 2014/11/28 |
| Last modified on | 2016/07/04 16:58:52 |
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Basic information
Public title
Associations of non-exercise activity thermogenesis with metabolic parameters in patients with glucose intolerance and type 2 diabetes
Acronym
Associations of non-exercise activity thermogenesis with metabolic parameters in patients with glucose intolerance and type 2 diabetes
Scientific Title
Associations of non-exercise activity thermogenesis with metabolic parameters in patients with glucose intolerance and type 2 diabetes
Scientific Title:Acronym
Associations of non-exercise activity thermogenesis with metabolic parameters in patients with glucose intolerance and type 2 diabetes
Region
| Japan |
Condition
Condition
impaired fasting glucose
impaired glucose tolerance
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The energy expenditure due to such physical activities, which is referred to as non-exercise activity thermogenesis (NEAT) and is defined as the energy expenditure due to physical activities other than volitional sports-like exercise or resistance training [9], has been reported to be associated with the risk of obesity. However, the extent to which light physical activity, including NEAT, is associated with metabolic risk factors is unclear, especially in relation to patients with type 2 diabetes. The aim of the present study was to examine the associations between daily light physical activity such as NEAT and various metabolic risk factors in impaired glucose metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
weight, body mass index, blood pressure, fasting plasma glucose, serum insulin, lipid profile
coefficient of variation of R-R intervals in the electrocardiogram, urinary albumin to creatinine ratio, ABI/PWV, augmentation index/central blood pressure
Key secondary outcomes
N/A
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who are diagnosed as having glucose intolerance or type 2 diabetes and do not take any hypoglycemic agents or cholesterol-lowering agents.
Key exclusion criteria
Individuals who engage in sports-like exercise or resistance training, have severe cardiovascular and/or respiratory diseases, physical disability are excluded.
Patients with type 1 diabetes are also excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Noda |
Organization
National Center for Global Health and Medicine
Division name
Department of Diabetes Research, Diabetes Research Center
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
mnoda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetaka Hamasaki |
Organization
National Center for Global Health and Medicine, Kohnodai Hospital
Division name
Internal Medicine
Zip code
Address
1-7-1, Kohnodai, Ichikawa, Chiba
TEL
047-372-3501
Homepage URL
hhamasaki78@gmail.com
Sponsor or person
Institute
Department of Internal Medicine, National Center for Global Health and Medicine, Kohnodai Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立国際医療研究センター国府台病院（千葉）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 80 patients were
studied. After adjustment for age and body mass index, in all subjects, physical activity level was negatively associated with waist
circumference (b = -0.124, p = 0.018) and fasting serum triglycerides (b = -0.239, p = 0.035), insulin (b = -0.224, p = 0.022).
In men, physical activity level was negatively associated with systolic blood pressure (b = -0.351, p = 0.044), fasting plasma
glucose (b = -0.369, p = 0.025) and insulin (b =-0.362, p = 0.012), and HOMA-IR (b = -0.371, p = 0.011). No significant
associations were found between physical activity level and metabolic risk factors in women.
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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective, observational study.
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2016 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018355
