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

SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Activity regime

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	2-step hyperinsulinemic euglycemic clamp	Day 5 of intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ex vivo skeletal muscle mitochondrial respiration	oxygraph	Day 5 of intervention period
substrate oxidation	indirect calorimetry RER	Day 5 of intervention period
Intrahepatic lipid content	magnetic resonance spectroscopy	Day 5 of intervention period
Blood pressure	average resting blood pressure over 30 minutes	Day 5 of intervention period
Plasma cardio metabolic markers	endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)	Day 5 of intervention period

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Dutch Heart Foundation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: insulin sensitivity; sitting time
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: NL62413.068.17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No