Consequences of Human Inactivity

NCT ID: NCT01828229

Last Updated: 2015-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inactivity Obesity Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

female inactivity and hypercaloric diet

inactivity and hypercaloric diet in women for two weeks

Group Type EXPERIMENTAL

female inactivity and hypercaloric diet

Intervention Type BEHAVIORAL

female inactivity and hypercaloric diet for 2 weeks

inactivity

Inactivity for two weeks

Group Type EXPERIMENTAL

inactivity

Intervention Type BEHAVIORAL

inactivity for 2 weeks

inactivity and hypercaloric diet

inactivity and hypercaloric diet for two weeks

Group Type EXPERIMENTAL

inactivity and hypercaloric diet

Intervention Type BEHAVIORAL

inactivity and hypercaloric diet for 2 weeks

normal activity and hypercaloric diet

Normal activity and hypercaloric diet for two weeks

Group Type EXPERIMENTAL

normal activity and hypercaloric diet

Intervention Type BEHAVIORAL

normal activity and hypercaloric diet for 2 weeks

inactivity and iso-caloric diet

inactivity and iso-caloric diet for two weeks

Group Type ACTIVE_COMPARATOR

inactivity and iso-caloric diet

Intervention Type BEHAVIORAL

inactivity and iso-caloric diet for 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

female inactivity and hypercaloric diet

female inactivity and hypercaloric diet for 2 weeks

Intervention Type BEHAVIORAL

inactivity

inactivity for 2 weeks

Intervention Type BEHAVIORAL

inactivity and hypercaloric diet

inactivity and hypercaloric diet for 2 weeks

Intervention Type BEHAVIORAL

normal activity and hypercaloric diet

normal activity and hypercaloric diet for 2 weeks

Intervention Type BEHAVIORAL

inactivity and iso-caloric diet

inactivity and iso-caloric diet for 2 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Diabetes in family
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anders Rasmussen Rinnov

Administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center og inflammation and metabolism, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen BK. Metabolic responses to reduced daily steps in healthy nonexercising men. JAMA. 2008 Mar 19;299(11):1261-3. doi: 10.1001/jama.299.11.1259. No abstract available.

Reference Type BACKGROUND
PMID: 18349087 (View on PubMed)

Krogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31.

Reference Type RESULT
PMID: 20044474 (View on PubMed)

Knudsen SH, Hansen LS, Pedersen M, Dejgaard T, Hansen J, Hall GV, Thomsen C, Solomon TP, Pedersen BK, Krogh-Madsen R. Changes in insulin sensitivity precede changes in body composition during 14 days of step reduction combined with overfeeding in healthy young men. J Appl Physiol (1985). 2012 Jul;113(1):7-15. doi: 10.1152/japplphysiol.00189.2011. Epub 2012 May 3.

Reference Type RESULT
PMID: 22556394 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-4-2009-082

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.