Consequences of Human Inactivity

Rigshospitalet

Status: Completed

Conditions: Obesity; Inactivity; Type 2 Diabetes

Treatments: Behavioral: female inactivity and hypercaloric diet; Behavioral: inactivity and hypercaloric diet; Behavioral: inactivity and iso-caloric diet; Behavioral: normal activity and hypercaloric diet; Behavioral: inactivity

Study type: Interventional

Funder types: Other

Identifiers

NCT01828229

H-4-2009-082

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Diabetes in family

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 5 patient groups

female inactivity and hypercaloric diet

Experimental group

Description:

inactivity and hypercaloric diet in women for two weeks

Treatment:

Behavioral: female inactivity and hypercaloric diet

inactivity

Experimental group

Description:

Inactivity for two weeks

Treatment:

Behavioral: inactivity

inactivity and hypercaloric diet

Experimental group

Description:

inactivity and hypercaloric diet for two weeks

Treatment:

Behavioral: inactivity and hypercaloric diet

normal activity and hypercaloric diet

Experimental group

Description:

Normal activity and hypercaloric diet for two weeks

Treatment:

Behavioral: normal activity and hypercaloric diet

inactivity and iso-caloric diet

Active Comparator group

Description:

inactivity and iso-caloric diet for two weeks

Treatment:

Behavioral: inactivity and iso-caloric diet