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OpenTrials
Completed

NCT Number: NCT01828229

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.

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Key information

Conditions

Inactivity Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Type 2 Diabetes

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center og inflammation and metabolism, Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Diabetes in family

Treatment and study plan

female inactivity and hypercaloric diet

Behavioral

female inactivity and hypercaloric diet for 2 weeks

Inactivity

Behavioral

inactivity for 2 weeks

inactivity and hypercaloric diet

Behavioral

inactivity and hypercaloric diet for 2 weeks

normal activity and hypercaloric diet

Behavioral

normal activity and hypercaloric diet for 2 weeks

inactivity and iso-caloric diet

Behavioral

inactivity and iso-caloric diet for 2 weeks

Primary outcomes

  1. Insulin sensitivity

    Time frame: 2 weeks

    Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test

Secondary outcomes

  1. visceral adiposity

    Time frame: 2 weeks

    Amount of visceral fat is determined by MRI scans

Other outcomes

  1. Cognitive function

    Time frame: 2 weeks

    Assessed by the Conner's Continuous Performance Test II 2000

  2. aerobic fitness

    Time frame: 2 weeks

    maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2013
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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