NCT00916019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

Enrollment Period

5.4 years

First QC Date

June 4, 2009

Last Update Submit

June 15, 2009

Conditions

Healthy

Keywords

gene expressionskeletal muscleHealthy men

Outcome Measures

Primary Outcomes (1)

  • Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression

    3 months

Study Arms (1)

exercise

EXPERIMENTAL

mild exercise training

Other: exercise training

Interventions

exercise trainingOTHER

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

exercise

Eligibility Criteria

Age19 Years - 32 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • People who undergone regular exercise for at least 2 years
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukuoka University

Fukuoka, Fukuoka, 814-0133, Japan

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hiroaki Tanaka, Ph.D.

    Fukuoka University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

July 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 16, 2009

Record last verified: 2009-06

Locations

JP(1)