Consequences of Human Inactivity

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01828229

Collaborator

(none)

Enrollment

Location

Arms

76.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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:

To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.

Condition or Disease	Intervention/Treatment	Phase
Inactivity Obesity Type 2 Diabetes	Behavioral: female inactivity and hypercaloric diet Behavioral: inactivity Behavioral: inactivity and hypercaloric diet Behavioral: normal activity and hypercaloric diet Behavioral: inactivity and iso-caloric diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Consequences of Human Inactivity

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: female inactivity and hypercaloric diet inactivity and hypercaloric diet in women for two weeks	Behavioral: female inactivity and hypercaloric diet female inactivity and hypercaloric diet for 2 weeks
Experimental: inactivity Inactivity for two weeks	Behavioral: inactivity inactivity for 2 weeks
Experimental: inactivity and hypercaloric diet inactivity and hypercaloric diet for two weeks	Behavioral: inactivity and hypercaloric diet inactivity and hypercaloric diet for 2 weeks
Experimental: normal activity and hypercaloric diet Normal activity and hypercaloric diet for two weeks	Behavioral: normal activity and hypercaloric diet normal activity and hypercaloric diet for 2 weeks
Active Comparator: inactivity and iso-caloric diet inactivity and iso-caloric diet for two weeks	Behavioral: inactivity and iso-caloric diet inactivity and iso-caloric diet for 2 weeks

Outcome Measures

Primary Outcome Measures

Insulin sensitivity [2 weeks]
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test

Secondary Outcome Measures

visceral adiposity [2 weeks]
Amount of visceral fat is determined by MRI scans

Other Outcome Measures

Cognitive function [2 weeks]
Assessed by the Conner's Continuous Performance Test II 2000
aerobic fitness [2 weeks]
maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer