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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02951624
Other study ID # 53476
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date July 15, 2018

Study information

Verified date December 2018
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile.


Description:

Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days.

Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet.

Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking.

Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking

Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking

All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 15, 2018
Est. primary completion date July 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Males, age 20-50 years, waist-to-height ratio = 0.5 and/or waist circumference = 102 cm.

Exclusion Criteria:

- Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz & Reibold 1990), contraindications to increased levels of physical activity.

Study Design


Intervention

Behavioral:
Control
Control intervention
Breaker
Short breaks of physical activity
Prolonger
longer breaks of physical activity
Intermediate
Intermediate breaks of physical activity

Locations

Country Name City State
Denmark Center for Physical Activity Research, Copenhagen University Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC post prandial glucose concentration 6 hours
Secondary AUC post prandial insulin concentration 6 hours
Secondary AUC post prandial c-peptide concentration 6 hours
Secondary AUC post prandial triglyceride concentration 6 hours
Secondary AUC post prandial total cholesterol concentration 6 hours
Secondary AUC post prandial ldl concentration 6 hours
Secondary AUC post prandial hdl concentration 6 hours
Secondary AUC post prandial glucagon concentration 6 hours
Secondary Mean 24 hour glucose concentration 24 hours
Secondary Variation in 24 hour glucose concentration 24 hours
Secondary Maximum in 24 hour glucose concentration 24 hours
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