Clinical trial NCT01828229: Consequences of Human Inactivity
Official title: Consequences of Human Inactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inactivity
Obesity
Type 2 Diabetes
Keywords: Inactivity
Obesity
Type 2 diabetes
glucose metabolism
Lipid metabolism
Cognitive function
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Normal physical active
* Healthy
* 18-40 y of age
* Non-smokers

Exclusion Criteria:

* Pregnancy
* Diabetes in family

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 2 weeks
Secondary outcomes:
measure: visceral adiposity
timeFrame: 2 weeks
Other outcomes:
measure: Cognitive function
timeFrame: 2 weeks
measure: aerobic fitness
timeFrame: 2 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Center og inflammation and metabolism, Rigshospitalet
Study officials:
References:
citation: 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.
citation: Krogh-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.
citation: Knudsen 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.