UMIN-CTR Clinical Trial

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

impaired fasting glucose
impaired glucose tolerance
type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

mnoda@hosp.ncgm.go.jp

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

Email

hhamasaki78@gmail.com

Institute

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

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立国際医療研究センター国府台病院（千葉）

Date of disclosure of the study information

2014

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 related information

prospective, observational study.

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