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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Activity regime
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring insulin sensitivity, sitting time

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sit regime

Sit less regime

Exercise regime

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Insulin sensitivity
2-step hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2019
Last Updated
January 19, 2021
Sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03912922
Brief Title
SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?
Acronym
SITLESS4
Official Title
SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
insulin sensitivity, sitting time

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sit regime
Arm Type
Experimental
Arm Description
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.
Arm Title
Sit less regime
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise regime
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Activity regime
Intervention Description
Activity regime of 4 days followed by a test day.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
2-step hyperinsulinemic euglycemic clamp
Time Frame
Day 5 of intervention period
Secondary Outcome Measure Information:
Title
ex vivo skeletal muscle mitochondrial respiration
Description
oxygraph
Time Frame
Day 5 of intervention period
Title
substrate oxidation
Description
indirect calorimetry RER
Time Frame
Day 5 of intervention period
Title
Intrahepatic lipid content
Description
magnetic resonance spectroscopy
Time Frame
Day 5 of intervention period
Title
Blood pressure
Description
average resting blood pressure over 30 minutes
Time Frame
Day 5 of intervention period
Title
Plasma cardio metabolic markers
Description
endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)
Time Frame
Day 5 of intervention period

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34510226
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.
Results Reference
derived

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

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