Clinical trial NCT03912922: SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?
Official title: SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: insulin sensitivity
sitting time
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2019-04-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Day 5 of intervention period
Secondary outcomes:
measure: ex vivo skeletal muscle mitochondrial respiration
timeFrame: Day 5 of intervention period
measure: substrate oxidation
timeFrame: Day 5 of intervention period
measure: Intrahepatic lipid content
timeFrame: Day 5 of intervention period
measure: Blood pressure
timeFrame: Day 5 of intervention period
measure: Plasma cardio metabolic markers
timeFrame: Day 5 of intervention period
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References:
citation: 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.