Consequences of Human Inactivity

June 17, 2015 updated by: Anders Rasmussen Rinnov, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Center og inflammation and metabolism, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Diabetes in family

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 2 weeks
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
Time Frame: 2 weeks
Amount of visceral fat is determined by MRI scans
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: 2 weeks
Assessed by the Conner's Continuous Performance Test II 2000
2 weeks
aerobic fitness
Time Frame: 2 weeks
maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2009-082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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