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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00916019
Other study ID # 19200049
Secondary ID
Status Completed
Phase N/A
First received June 4, 2009
Last updated June 15, 2009
Start date July 2002
Est. completion date December 2007

Study information

Verified date June 2009
Source Fukuoka University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Interventional

Clinical Trial Summary

The investigators have previously shown that mild exercise training at the level of lactate threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity and insulin-independent glucose disposal of glucose effectiveness, without changes in body weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus these beneficial effects are likely related to a number of adaptations that occur in skeletal muscle as response to exercise. In the current study, the investigators hypothesised that a single bout of mild exercise performed at LT would be a physiological stimulator of skeletal muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene (i.e., training) for 12 weeks would induce coordinated increases in a large number of metabolic genes, as well as other genes potentially important in the prevention of insulin resistance and metabolic syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 32 Years
Eligibility Inclusion Criteria:

- Men who were all in good health

- All individuals were free from diabetes and none were taking any medications

- All subjects were asked not to change their normal dietary habits, and not to engage in any strenuous physical activity

Exclusion Criteria:

- People who undergone regular exercise for at least 2 years

- Smokers

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
exercise training
60 min of low-intensity exercise, 5 days/week, 12 weeks

Locations

Country Name City State
Japan Fukuoka University Fukuoka

Sponsors (1)

Lead Sponsor Collaborator
Fukuoka University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression 3 months No
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