Overweight and ObesitySITLESS4NCT03912922
SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?
A study testing Activity regime in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Activity regime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2017to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Activity regime
- Keywords
- insulin sensitivity, sitting time
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity regimeOther
Activity regime of 4 days followed by a test day.
| Study group | Role | What they receive |
|---|---|---|
| Sit regime | Experimental | 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. Receives: Other: Activity regime |
| Sit less regime | Experimental | 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. Receives: Other: Activity regime |
| Exercise regime | Experimental | 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. Receives: Other: Activity regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
2-step hyperinsulinemic euglycemic clamp
Measured: Day 5 of intervention period
Secondary outcomes (5)
ex vivo skeletal muscle mitochondrial respiration
oxygraph
Measured: Day 5 of intervention period
substrate oxidation
indirect calorimetry RER
Measured: Day 5 of intervention period
Intrahepatic lipid content
magnetic resonance spectroscopy
Measured: Day 5 of intervention period
Blood pressure
average resting blood pressure over 30 minutes
Measured: Day 5 of intervention period
Plasma cardio metabolic markers
endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)
Measured: Day 5 of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start15 Dec 2017
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912922
- Sponsor's protocol ID
- NL62413.068.17
- Acronym
- SITLESS4
- Status last verified
- Jan 2021
- First submitted
- 3 Apr 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34510226
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT03912922
- Acronym / sponsor ID
- SITLESS4 / NL62413.068.17
- Conditions
- Overweight and Obesity
- Keywords
- insulin sensitivity, sitting time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sit regime | Experimental | Other: Activity regimeSubjects 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. |
| Sit less regime | Experimental | Other: Activity regimeSubjects 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. |
| Exercise regime | Experimental | Other: Activity regimeSubjects 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Caucasian
- Postmenopausal women
- Aged 45-70 years at start of the study
- Body mass index (BMI) 25 - 35 kg/m2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity regimeActivity regime of 4 days followed by a test day. | Other | Exercise regime, Sit less regime, Sit regime |
Primary outcome
Insulin sensitivity
Time frame: Day 5 of intervention period
2-step hyperinsulinemic euglycemic clamp
5 secondary outcomes
ex vivo skeletal muscle mitochondrial respiration
Time frame: Day 5 of intervention period
substrate oxidation
Time frame: Day 5 of intervention period
Intrahepatic lipid content
Time frame: Day 5 of intervention period
Blood pressure
Time frame: Day 5 of intervention period
Plasma cardio metabolic markers
Time frame: Day 5 of intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 34510226Remie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity regime in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Day 5 of intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03912922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.