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CompletedNCT03912922SITLESS4Updated Jan 20, 2021

SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?

An interventional study of Activity regime in Overweight and Obesity, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to female participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-20.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2017, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
Female
01

Study summary

Research has shown that replacing sitting time with low intensity physical activity (such as slowly walking and standing) has beneficial effects on metabolic health, like insulin sensitivity, comparable to improvements after sitting all day in combination with 1h streneous exercise.

The main objective of this study is to investigate the underlying mechanisms responsible for improved insulin sensitivity after 4 days of sitting less compared to sitting and exercise in healthy obese women. Our secondary objective is to investigate the effects of sitting less on cardio metabolic parameters.

02

Conditions studied

  • Overweight and Obesity

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Keywords

  • insulin sensitivity
  • sitting time
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 12 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Signed informed consent
  • Caucasian
  • Postmenopausal women
  • Aged 45-70 years at start of the study
  • Body mass index (BMI) 25 - 35 kg/m2
  • Stable dietary habits (no weight loss or gain >5kg in the past 3 months)
  • Sedentary lifestyle (not more than 2,5 hours of exercise per week in the past 3 months)

Exclusion criteria

Exclusion Criteria:

  • Not able to complete the sitless try-out day according to the protocol
  • Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
  • No use of medication interfering with investigated study parameters (as determined by responsible physician)
  • Alcohol consumption of >2 servings per day
  • Smoking in the past 6 months
  • Participation in another biomedical trial which may have an effect on insulin sensitivity less than one month before the start of the study (screening visit)
  • Mental or physical disability which interferes with physical activity
  • Subjects with contra-indications for magnetic resonance imaging (MRI)
  • Reported participation in night shift work 2 weeks prior to the start of the study (screening visit) and during study participation. Night work is defined as working between midnight and 6.00 AM.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Sit regime

    Subjects will follow the sit regime during four days. Each day consists of 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping.

    Other: Activity regime

  • Experimental
    Sit less regime

    Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 3 hours walking, 4 hours standing and 8 hours sleeping.

    Other: Activity regime

  • Experimental
    Exercise regime

    Subjects will follow the exercise regime during four days. Each day will consist of 13 hours sitting, 1 hour walking, 1 hour standing, 1 hour exercise and 8 hours sleeping. The cycle session will be at approximately 60% maximal power. Exact cycling intensity and duration will be calculated to ensure equal total energy expenditure between the sitting less and the exercise regime.

    Other: Activity regime

Interventions

  • OtherActivity regime

    Activity regime of 4 days followed by a test day.

06

What researchers measure

Primary outcomes

  1. Insulin sensitivity

    2-step hyperinsulinemic euglycemic clamp

    Time frame: Day 5 of intervention period

Secondary outcomes

  1. ex vivo skeletal muscle mitochondrial respiration

    oxygraph

    Time frame: Day 5 of intervention period

  2. substrate oxidation

    indirect calorimetry RER

    Time frame: Day 5 of intervention period

  3. Intrahepatic lipid content

    magnetic resonance spectroscopy

    Time frame: Day 5 of intervention period

  4. Blood pressure

    average resting blood pressure over 30 minutes

    Time frame: Day 5 of intervention period

  5. Plasma cardio metabolic markers

    endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)

    Time frame: Day 5 of intervention period

07

Study locations

1 site
  • Maastricht University Medical Centre
    Maastricht, Netherlands
08

References and documents

Publications

  • Remie CME, Janssens GE, Bilet L, van Weeghel M, Duvivier BMFM, de Wit VHW, Connell NJ, Jorgensen JA, Schomakers BV, Schrauwen-Hinderling VB, Hoeks J, Hesselink MKC, Phielix E, Houtkooper RH, Schrauwen P. Sitting less elicits metabolic responses similar to exercise and enhances insulin sensitivity in postmenopausal women. Diabetologia. 2021 Dec;64(12):2817-2828. doi: 10.1007/s00125-021-05558-5. Epub 2021 Sep 12. PubMed 34510226 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03912922
Lead sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation
Responsible party
Sponsor
First posted
Apr 11, 2019
Start date
Dec 15, 2017
Primary completion
Mar 13, 2020
Completion
Mar 13, 2020
Last update
Jan 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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