SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?
SITLESS4
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedJanuary 20, 2021
January 1, 2021
2.2 years
April 3, 2019
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity
2-step hyperinsulinemic euglycemic clamp
Day 5 of intervention period
Secondary Outcomes (5)
ex vivo skeletal muscle mitochondrial respiration
Day 5 of intervention period
substrate oxidation
Day 5 of intervention period
Intrahepatic lipid content
Day 5 of intervention period
Blood pressure
Day 5 of intervention period
Plasma cardio metabolic markers
Day 5 of intervention period
Study Arms (3)
Sit regime
EXPERIMENTALSubjects 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.
Sit less regime
EXPERIMENTALSubjects 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.
Exercise regime
EXPERIMENTALSubjects 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.
Interventions
Activity regime of 4 days followed by a test day.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Dutch Heart Foundationcollaborator
Study Sites (1)
Maastricht University Medical Centre
Maastricht, Netherlands
Related Publications (1)
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.
PMID: 34510226DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 11, 2019
Study Start
December 15, 2017
Primary Completion
March 13, 2020
Study Completion
March 13, 2020
Last Updated
January 20, 2021
Record last verified: 2021-01