Back to results

Consequences of Human Inactivity

Primary Purpose

Inactivity, Obesity, Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

female inactivity and hypercaloric diet

inactivity

inactivity and hypercaloric diet

normal activity and hypercaloric diet

inactivity and iso-caloric diet

About this trial

This is an interventional prevention trial for Inactivity focused on measuring Inactivity, Obesity, Type 2 diabetes, glucose metabolism, Lipid metabolism, Cognitive function

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Diabetes in family

Sites / Locations

Center og inflammation and metabolism, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

female inactivity and hypercaloric diet

inactivity

inactivity and hypercaloric diet

normal activity and hypercaloric diet

inactivity and iso-caloric diet

Arm Description

inactivity and hypercaloric diet in women for two weeks

Inactivity for two weeks

inactivity and hypercaloric diet for two weeks

Normal activity and hypercaloric diet for two weeks

inactivity and iso-caloric diet for two weeks

Outcomes

Primary Outcome Measures

Insulin sensitivity

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

Secondary Outcome Measures

visceral adiposity

Amount of visceral fat is determined by MRI scans

Full Information

NCT ID

NCT01828229

First Posted

April 5, 2013

Last Updated

June 17, 2015

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01828229

Brief Title

Consequences of Human Inactivity

Official Title

Consequences of Human Inactivity

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inactivity, Obesity, Type 2 Diabetes

Keywords

Inactivity, Obesity, Type 2 diabetes, glucose metabolism, Lipid metabolism, Cognitive function

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

female inactivity and hypercaloric diet

Arm Type

Experimental

Arm Description

inactivity and hypercaloric diet in women for two weeks

Arm Title

inactivity

Arm Type

Experimental

Arm Description

Inactivity for two weeks

Arm Title

inactivity and hypercaloric diet

Arm Type

Experimental

Arm Description

inactivity and hypercaloric diet for two weeks

Arm Title

normal activity and hypercaloric diet

Arm Type

Experimental

Arm Description

Normal activity and hypercaloric diet for two weeks

Arm Title

inactivity and iso-caloric diet

Arm Type

Active Comparator

Arm Description

inactivity and iso-caloric diet for two weeks

Intervention Type

Behavioral

Intervention Name(s)

female inactivity and hypercaloric diet

Intervention Description

female inactivity and hypercaloric diet for 2 weeks

Intervention Type

Behavioral

Intervention Name(s)

inactivity

Intervention Description

inactivity for 2 weeks

Intervention Type

Behavioral

Intervention Name(s)

inactivity and hypercaloric diet

Intervention Description

inactivity and hypercaloric diet for 2 weeks

Intervention Type

Behavioral

Intervention Name(s)

normal activity and hypercaloric diet

Intervention Description

normal activity and hypercaloric diet for 2 weeks

Intervention Type

Behavioral

Intervention Name(s)

inactivity and iso-caloric diet

Intervention Description

inactivity and iso-caloric diet for 2 weeks

Primary Outcome Measure Information:

Title

Insulin sensitivity

Description

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

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

visceral adiposity

Description

Amount of visceral fat is determined by MRI scans

Time Frame

2 weeks

Other Pre-specified Outcome Measures:

Title

Cognitive function

Description

Assessed by the Conner's Continuous Performance Test II 2000

Time Frame

2 weeks

Title

aerobic fitness

Description

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

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Center og inflammation and metabolism, Rigshospitalet

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

18349087

Citation

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.

Results Reference

background

PubMed Identifier

20044474

Citation

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. Erratum In: J Appl Physiol. 2010 May;108(5):1034.

Results Reference

result

PubMed Identifier

22556394

Citation

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. Erratum In: J Appl Physiol (1985). 2015 Feb 15;118(4):504.

Results Reference

result

Learn more about this trial

Consequences of Human Inactivity

We'll reach out to this number within 24 hrs