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SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? (SITLESS4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912922
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Dutch Heart Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Other: Activity regime Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Arm Intervention/treatment
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
Activity regime of 4 days followed by a test day.

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
Activity regime of 4 days followed by a test day.

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
Activity regime of 4 days followed by a test day.




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Day 5 of intervention period ]
    2-step hyperinsulinemic euglycemic clamp


Secondary Outcome Measures :
  1. ex vivo skeletal muscle mitochondrial respiration [ Time Frame: Day 5 of intervention period ]
    oxygraph

  2. substrate oxidation [ Time Frame: Day 5 of intervention period ]
    indirect calorimetry RER

  3. Intrahepatic lipid content [ Time Frame: Day 5 of intervention period ]
    magnetic resonance spectroscopy

  4. Blood pressure [ Time Frame: Day 5 of intervention period ]
    average resting blood pressure over 30 minutes

  5. Plasma cardio metabolic markers [ Time Frame: Day 5 of intervention period ]
    endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912922


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Heart Foundation

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03912922    
Other Study ID Numbers: NL62413.068.17
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
insulin sensitivity
sitting time
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms