UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Associations of non-exercise activity thermogenesis with metabolic parameters in patients with glucose intolerance and type 2 diabetes
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Mitsuhiko Noda
Organization	National Center for Global Health and Medicine
Division name	Department of Diabetes Research, Diabetes Research Center
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	mnoda@hosp.ncgm.go.jp

Public contact
Name of contact person	Hidetaka Hamasaki
Organization	National Center for Global Health and Medicine, Kohnodai Hospital
Division name	Internal Medicine
Address	1-7-1, Kohnodai, Ichikawa, Chiba
TEL	047-372-3501
Homepage URL
Email	hhamasaki78@gmail.com

Sponsor
Institute	Department of Internal Medicine, National Center for Global Health and Medicine, Kohnodai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018355