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

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03912922
• Collaborator: Dutch Heart Foundation (Other)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 26.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Other: Activity regime	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms
• Actual Study Start Date: Dec 15, 2017
• Actual Primary Completion Date: Mar 13, 2020
• Actual Study Completion Date: Mar 13, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Insulin sensitivity [Day 5 of intervention period]

   2-step hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

1. ex vivo skeletal muscle mitochondrial respiration [Day 5 of intervention period]

   oxygraph

2. substrate oxidation [Day 5 of intervention period]

   indirect calorimetry RER

3. Intrahepatic lipid content [Day 5 of intervention period]

   magnetic resonance spectroscopy

4. Blood pressure [Day 5 of intervention period]

   average resting blood pressure over 30 minutes

5. Plasma cardio metabolic markers [Day 5 of intervention period]

   endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Centre	Maastricht		Netherlands

Sponsors and Collaborators

• Maastricht University Medical Center
• Dutch Heart Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT03912922
• Other Study ID Numbers: NL62413.068.17
• First Posted: Apr 11, 2019
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maastricht University Medical Center: insulin sensitivity; sitting time
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jan 20, 2021