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

Overweight and Obesity Clinical Trial

— SITLESS4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912922
• Other study ID #: NL62413.068.17
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: March 13, 2020

Study information

• Verified date: January 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Activity regime
Activity regime of 4 days followed by a test day.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	2-step hyperinsulinemic euglycemic clamp	Day 5 of intervention period
Secondary	ex vivo skeletal muscle mitochondrial respiration	oxygraph	Day 5 of intervention period
Secondary	substrate oxidation	indirect calorimetry RER	Day 5 of intervention period
Secondary	Intrahepatic lipid content	magnetic resonance spectroscopy	Day 5 of intervention period
Secondary	Blood pressure	average resting blood pressure over 30 minutes	Day 5 of intervention period
Secondary	Plasma cardio metabolic markers	endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)	Day 5 of intervention period