Consequences of Human Inactivity

Not Applicable

Completed

• Conditions: Obesity; Inactivity; Type 2 Diabetes
• Interventions: Behavioral: normal activity and hypercaloric diet; Behavioral: inactivity and iso-caloric diet; Behavioral: inactivity; Behavioral: female inactivity and hypercaloric diet; Behavioral: inactivity and hypercaloric diet

• Registration Number: NCT01828229
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-10
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Diabetes in family

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal activity and hypercaloric diet	normal activity and hypercaloric diet	Normal activity and hypercaloric diet for two weeks
inactivity and iso-caloric diet	inactivity and iso-caloric diet	inactivity and iso-caloric diet for two weeks
inactivity	inactivity	Inactivity for two weeks
female inactivity and hypercaloric diet	female inactivity and hypercaloric diet	inactivity and hypercaloric diet in women for two weeks
inactivity and hypercaloric diet	inactivity and hypercaloric diet	inactivity and hypercaloric diet for two weeks

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	2 weeks	Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
visceral adiposity	2 weeks	Amount of visceral fat is determined by MRI scans

Trial Locations

Locations (1)

Center og inflammation and metabolism, Rigshospitalet; 🇩🇰 Copenhagen, Denmark