Consequences of Human Inactivity
1 other identifier
interventional
50
1 country
1
Brief Summary
Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes. The present protocol is divided in several in several sub-studies:
- 1.To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
- 2.To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
- 3.To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 5, 2013
CompletedFirst Posted
Study publicly available on registry
April 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 18, 2015
June 1, 2015
6.4 years
April 5, 2013
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test
2 weeks
Secondary Outcomes (1)
visceral adiposity
2 weeks
Other Outcomes (2)
Cognitive function
2 weeks
aerobic fitness
2 weeks
Study Arms (5)
female inactivity and hypercaloric diet
EXPERIMENTALinactivity and hypercaloric diet in women for two weeks
inactivity
EXPERIMENTALInactivity for two weeks
inactivity and hypercaloric diet
EXPERIMENTALinactivity and hypercaloric diet for two weeks
normal activity and hypercaloric diet
EXPERIMENTALNormal activity and hypercaloric diet for two weeks
inactivity and iso-caloric diet
ACTIVE COMPARATORinactivity and iso-caloric diet for two weeks
Interventions
female inactivity and hypercaloric diet for 2 weeks
inactivity and hypercaloric diet for 2 weeks
normal activity and hypercaloric diet for 2 weeks
inactivity and iso-caloric diet for 2 weeks
Eligibility Criteria
You may qualify if:
- Normal physical active
- Healthy
- y of age
- Non-smokers
You may not qualify if:
- Pregnancy
- Diabetes in family
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center og inflammation and metabolism, Rigshospitalet
Copenhagen, Denmark
Related Publications (3)
Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen BK. Metabolic responses to reduced daily steps in healthy nonexercising men. JAMA. 2008 Mar 19;299(11):1261-3. doi: 10.1001/jama.299.11.1259. No abstract available.
PMID: 18349087BACKGROUNDKrogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31.
PMID: 20044474RESULTKnudsen SH, Hansen LS, Pedersen M, Dejgaard T, Hansen J, Hall GV, Thomsen C, Solomon TP, Pedersen BK, Krogh-Madsen R. Changes in insulin sensitivity precede changes in body composition during 14 days of step reduction combined with overfeeding in healthy young men. J Appl Physiol (1985). 2012 Jul;113(1):7-15. doi: 10.1152/japplphysiol.00189.2011. Epub 2012 May 3.
PMID: 22556394RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Administrator
Study Record Dates
First Submitted
April 5, 2013
First Posted
April 10, 2013
Study Start
January 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 18, 2015
Record last verified: 2015-06