Consequences of Human Inactivity

Obesity Clinical Trial

Official title:

Consequences of Human Inactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828229
• Other study ID #: H-4-2009-082
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: June 17, 2015
• Start date: January 2009
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normal physical active

• Healthy

• 18-40 y of age

• Non-smokers

Exclusion Criteria:

• Pregnancy

• Diabetes in family

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Inactivity
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• female inactivity and hypercaloric diet
female inactivity and hypercaloric diet for 2 weeks
• inactivity
inactivity for 2 weeks
• inactivity and hypercaloric diet
inactivity and hypercaloric diet for 2 weeks
• normal activity and hypercaloric diet
normal activity and hypercaloric diet for 2 weeks
• inactivity and iso-caloric diet
inactivity and iso-caloric diet for 2 weeks

Locations

Country	Name	City	State
Denmark	Center og inflammation and metabolism, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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 — View 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. d — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function	Assessed by the Conner's Continuous Performance Test II 2000	2 weeks	No
Other	aerobic fitness	maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer	2 weeks	No
Primary	Insulin sensitivity	Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test	2 weeks	No
Secondary	visceral adiposity	Amount of visceral fat is determined by MRI scans	2 weeks	No