Consequences of Human Inactivity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01828229
First received: April 5, 2013
Last updated: April 9, 2013
Last verified: April 2013

April 5, 2013
April 9, 2013
January 2009
January 2014   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test
Same as current
Complete list of historical versions of study NCT01828229 on ClinicalTrials.gov Archive Site
visceral adiposity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Amount of visceral fat is determined by MRI scans
Same as current
  • Cognitive function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessed by the Conner's Continuous Performance Test II 2000
  • aerobic fitness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer
Same as current
 
Consequences of Human Inactivity
Consequences of Human Inactivity

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Inactivity
  • Obesity
  • Type 2 Diabetes
  • Behavioral: female inactivity and hypercaloric diet
    female inactivity and hypercaloric diet for 2 weeks
  • Behavioral: inactivity
    inactivity for 2 weeks
  • Behavioral: inactivity and hypercaloric diet
    inactivity and hypercaloric diet for 2 weeks
  • Behavioral: normal activity and hypercaloric diet
    normal activity and hypercaloric diet for 2 weeks
  • Behavioral: inactivity and iso-caloric diet
    inactivity and iso-caloric diet for 2 weeks
  • Experimental: female inactivity and hypercaloric diet
    inactivity and hypercaloric diet in women for two weeks
    Intervention: Behavioral: female inactivity and hypercaloric diet
  • Experimental: inactivity
    Inactivity for two weeks
    Intervention: Behavioral: inactivity
  • Experimental: inactivity and hypercaloric diet
    inactivity and hypercaloric diet for two weeks
    Intervention: Behavioral: inactivity and hypercaloric diet
  • Experimental: normal activity and hypercaloric diet
    Normal activity and hypercaloric diet for two weeks
    Intervention: Behavioral: normal activity and hypercaloric diet
  • Active Comparator: inactivity and iso-caloric diet
    inactivity and iso-caloric diet for two weeks
    Intervention: Behavioral: inactivity and iso-caloric diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Diabetes in family
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01828229
H-4-2009-082
Yes
Inge Holm, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP