Consequences of Human Inactivity

Study Overview
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Brief Summary
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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.

Official Title
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Consequences of Human Inactivity

Conditions
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Inactivity, Obesity, Type 2 Diabetes

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal physical active Healthy 18-40 y of age Non-smokers Exclusion Criteria: Pregnancy Diabetes in family

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: female inactivity and hypercaloric diet<br>inactivity and hypercaloric diet in women for two weeks | Behavioral: female inactivity and hypercaloric diet<br>* female inactivity and hypercaloric diet for 2 weeks<br>|
| Experimental: inactivity<br>Inactivity for two weeks | Behavioral: inactivity<br>* inactivity for 2 weeks<br>|
| Experimental: inactivity and hypercaloric diet<br>inactivity and hypercaloric diet for two weeks | Behavioral: inactivity and hypercaloric diet<br>* inactivity and hypercaloric diet for 2 weeks<br>|
| Experimental: normal activity and hypercaloric diet<br>Normal activity and hypercaloric diet for two weeks | Behavioral: normal activity and hypercaloric diet<br>* normal activity and hypercaloric diet for 2 weeks<br>|
| Active Comparator: inactivity and iso-caloric diet<br>inactivity and iso-caloric diet for two weeks | Behavioral: inactivity and iso-caloric diet<br>* inactivity and iso-caloric diet for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visceral adiposity | Amount of visceral fat is determined by MRI scans | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inactivity, Obesity, Type 2 diabetes, glucose metabolism, Lipid metabolism, Cognitive function