Metabolic SyndromeNCT03101228
Medical and Physiological Benefits of Reduced Sitting
A study testing Reduced sitting in people with Metabolic Syndrome and Physical Activity, run by Turku University Hospital at 1 site in Finland.
Trial summary
The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Physical Activity, Insulin Resistance
- What is being tested?
- Reduced sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFinland
- Study dates
- 25 Apr 2017to 4 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
- Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
- BMI 25-40
- Blood pressure < 160/100 mmHg
- Fasting plasma glucose < 7.0 mmol/l
- Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009
Who cannot join
- History of a cardiac event
- Insulin or medically treated diabetes
- Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
- Presence of ferromagnetic objects that would make MR imaging contraindicated
- Abundant use of alcohol
- Use of narcotics
Show all 9Show fewer
- Smoking of tobacco or consuming snuff tobacco
- Diagnosed depressive or bipolar disorder
- Previous PET imaging or considerable exposure to radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.
- Being tested
- Reduced sitting
- Keywords
- Physical Activity, Metabolic Syndrome, Insulin Sensitivity, Cardiovascular Risk Factor, Sedentary Lifestyle, Accelerometry
- Medical subject headings
- Metabolic Syndrome, Motor Activity, Insulin Resistance, Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced sittingBehavioural
Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Reduced sitting | Experimental | Objectively measured daily inactive time will be reduced by one hour compared to the baseline. Receives: Behavioral: Reduced sitting |
| Control | No intervention | Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in whole-body insulin sensitivity
M-value during the hyperinsulinemic euglycemic clamp
Measured: The change from baseline to 6 months
The change in skeletal muscle insulin-stimulated glucose uptake
Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp
Measured: The change from baseline to 6 months
Secondary outcomes (10)
daily sitting hours
Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer
Measured: through study completion, an average of 6 months
daily hours spent physically active
Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer
Measured: through study completion, an average of 6 months
The change in liver adiposity
Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)
Measured: The change from baseline to 6 months
The change in maximal oxygen uptake
Maximal oxygen uptake (VO2peak) will be determined by cycle ergometry with direct respiratory measurements. Exercise intensity will be started at 50 W and the intensity will be increased by 25 W at every two minutes until the criteria used to establish the VO2peak are met. The criteria used to establish the VO2peak are a plateau in VO2 despite of an increase in intensity and a respiratory quotient greater than 1.1. or volitional fatigue.
Measured: The change from baseline to 6 months
The change in body fat percentage
Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.
Measured: The change from baseline to 3 months
The change in body fat percentage
Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.
Measured: The change from baseline to 6 months
The change in plasma glucose
Plasma glucose content will be measured from fasting venous blood samples using standard assays
Measured: The change from baseline to 3 months
The change in plasma glucose
Plasma glucose content will be measured from fasting venous blood samples using standard assays
Measured: The change from baseline to 6 months
The change in HbA1c
Glycated hemoglobin will be measured from fasting venous blood samples using standard assays
Measured: The change from baseline to 3 months
The change in HbA1c
Glycated hemoglobin will be measured from fasting venous blood samples using standard assays
Measured: The change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start25 Apr 2017
- Primary completion14 Feb 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- A parallel-group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- UKK Institute
- Responsible party
- Principal investigator, Ilkka Heinonen, University of Turku
- Investigators
- Juhani Knuuti, Professor, Study chair, Turku PET Centre, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101228
- Sponsor's protocol ID
- T91/2017
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD of the main outcome measures will be opened if possible.
Publications
Norha J, Saarenhovi M, Kallio P, Sjoros T, Garthwaite T, Laine S, Houttu N, Laitinen K, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Knuuti J, Kalliokoski KK, Heinonen IHA. Effects of Reducing Sedentary Behaviour on Cardiac Structure and Function at Rest and During Exercise: A 6-Month Randomized Controlled Trial. CJC Open. 2025 Sep 16;8(1):69-81. doi: 10.1016/j.cjco.2025.09.005. eCollection 2026 Jan.
PubMed 41732582Norha J, Sjoros T, Garthwaite T, Laine S, Laitinen K, Houttu N, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Knuuti J, Kalliokoski KK, Heinonen IHA. Secondary analysis of a randomised controlled trial on reducing sedentary behaviour and its effects on quality of life and wellbeing. Sci Rep. 2025 Oct 22;15(1):36861. doi: 10.1038/s41598-025-20836-7.
PubMed 41125692Garthwaite T, Sjoros T, Laine S, Koivumaki M, Vaha-Ypya H, Norha J, Kallio P, Saarenhovi M, Loyttyniemi E, Sievanen H, Houttu N, Laitinen K, Kalliokoski KK, Vasankari T, Knuuti J, Heinonen I. Successfully Reducing Sitting Time Can Improve Metabolic Flexibility. Scand J Med Sci Sports. 2025 Aug;35(8):e70113. doi: 10.1111/sms.70113.
PubMed 40781908Ylinen VP, Sjoros T, Laine S, Garthwaite T, Norha J, Vaha-Ypya H, Loyttyniemi E, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IH. Sedentary behavior reduction and blood lipids in adults with metabolic syndrome: a 6-month randomized controlled trial. Sci Rep. 2024 Oct 16;14(1):24241. doi: 10.1038/s41598-024-75579-8.
PubMed 39414998Norha J, Sjoros T, Garthwaite T, Laine S, Verho T, Saunavaara V, Laitinen K, Houttu N, Hirvonen J, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Kalliokoski K, Heinonen I. Effects of reducing sedentary behaviour on back pain, paraspinal muscle insulin sensitivity and muscle fat fraction and their associations: a secondary analysis of a 6-month randomised controlled trial. BMJ Open. 2024 Sep 28;14(9):e084305. doi: 10.1136/bmjopen-2024-084305.
PubMed 39343453Sjoros T, Norha J, Johansson R, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Tiredness after work associates with less leisure-time physical activity. Sci Rep. 2024 Apr 4;14(1):7965. doi: 10.1038/s41598-024-58775-4.
PubMed 38575674Sjoros T, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Koivumaki M, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Reducing Sedentary Time and Whole-Body Insulin Sensitivity in Metabolic Syndrome: A 6-Month Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Mar 1;55(3):342-353. doi: 10.1249/MSS.0000000000003054. Epub 2022 Oct 13.
PubMed 36251378Norha J, Hautala AJ, Sjoros T, Laine S, Garthwaite T, Knuuti J, Loyttyniemi E, Vaha-Ypya H, Sievanen H, Vasankari T, Heinonen IHA. Standing time and daily proportion of sedentary time are associated with pain-related disability in a one month accelerometer measurement in adults with overweight or obesity. Scand J Pain. 2021 Sep 27;22(2):317-324. doi: 10.1515/sjpain-2021-0108. Print 2022 Apr 26.
PubMed 34582633Sjoros T, Vaha-Ypya H, Laine S, Garthwaite T, Lahesmaa M, Laurila SM, Latva-Rasku A, Savolainen A, Miikkulainen A, Loyttyniemi E, Sievanen H, Kalliokoski KK, Knuuti J, Vasankari T, Heinonen IHA. Both sedentary time and physical activity are associated with cardiometabolic health in overweight adults in a 1 month accelerometer measurement. Sci Rep. 2020 Nov 25;10(1):20578. doi: 10.1038/s41598-020-77637-3.
PubMed 33239818
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
- ClinicalTrials.gov ID
- NCT03101228
- Acronym / sponsor ID
- T91/2017
- Keywords
- Physical Activity, Metabolic Syndrome, Insulin Sensitivity, Cardiovascular Risk Factor, Sedentary Lifestyle, Accelerometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- UKK Institute
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 5 Apr 2017 (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.
The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Reduced sitting | Experimental | Behavioral: Reduced sittingObjectively measured daily inactive time will be reduced by one hour compared to the baseline. |
| Control | No intervention | –Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
- Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
- BMI 25-40
- Blood pressure < 160/100 mmHg
- Fasting plasma glucose < 7.0 mmol/l
Key exclusion criteria (9 listed)
- History of a cardiac event
- Insulin or medically treated diabetes
- Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
- Presence of ferromagnetic objects that would make MR imaging contraindicated
- Abundant use of alcohol
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 |
|---|---|---|
| Reduced sittingSubjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels. | Behavioural | Reduced sitting |
Primary outcome
The change in whole-body insulin sensitivity
Time frame: The change from baseline to 6 months
M-value during the hyperinsulinemic euglycemic clamp
The change in skeletal muscle insulin-stimulated glucose uptake
Time frame: The change from baseline to 6 months
Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp
10 secondary outcomes
daily sitting hours
Time frame: through study completion, an average of 6 months
daily hours spent physically active
Time frame: through study completion, an average of 6 months
The change in liver adiposity
Time frame: The change from baseline to 6 months
The change in maximal oxygen uptake
Time frame: The change from baseline to 6 months
The change in body fat percentage
Time frame: The change from baseline to 3 months
The change in body fat percentage
Time frame: The change from baseline to 6 months
The change in plasma glucose
Time frame: The change from baseline to 3 months
The change in plasma glucose
Time frame: The change from baseline to 6 months
The change in HbA1c
Time frame: The change from baseline to 3 months
The change in HbA1c
Time frame: The change from baseline to 6 months
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 8 Apr 2020.
- Derived from this study: PubMed 41732582Norha J, Saarenhovi M, Kallio P, Sjoros T, Garthwaite T, Laine S, Houttu N, Laitinen K, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Knuuti J, Kalliokoski KK, Heinonen IHA. Effects of Reducing Sedentary Behaviour on Cardiac Structure and Function at Rest and During Exercise: A 6-Month Randomized Controlled Trial. CJC Open. 2025 Sep 16;8(1):69-81. doi: 10.1016/j.cjco.2025.09.005. eCollection 2026 Jan.
- Derived from this study: PubMed 41125692Norha J, Sjoros T, Garthwaite T, Laine S, Laitinen K, Houttu N, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Knuuti J, Kalliokoski KK, Heinonen IHA. Secondary analysis of a randomised controlled trial on reducing sedentary behaviour and its effects on quality of life and wellbeing. Sci Rep. 2025 Oct 22;15(1):36861. doi: 10.1038/s41598-025-20836-7.
- Derived from this study: PubMed 40781908Garthwaite T, Sjoros T, Laine S, Koivumaki M, Vaha-Ypya H, Norha J, Kallio P, Saarenhovi M, Loyttyniemi E, Sievanen H, Houttu N, Laitinen K, Kalliokoski KK, Vasankari T, Knuuti J, Heinonen I. Successfully Reducing Sitting Time Can Improve Metabolic Flexibility. Scand J Med Sci Sports. 2025 Aug;35(8):e70113. doi: 10.1111/sms.70113.
- Derived from this study: PubMed 39414998Ylinen VP, Sjoros T, Laine S, Garthwaite T, Norha J, Vaha-Ypya H, Loyttyniemi E, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IH. Sedentary behavior reduction and blood lipids in adults with metabolic syndrome: a 6-month randomized controlled trial. Sci Rep. 2024 Oct 16;14(1):24241. doi: 10.1038/s41598-024-75579-8.
- Derived from this study: PubMed 39343453Norha J, Sjoros T, Garthwaite T, Laine S, Verho T, Saunavaara V, Laitinen K, Houttu N, Hirvonen J, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Kalliokoski K, Heinonen I. Effects of reducing sedentary behaviour on back pain, paraspinal muscle insulin sensitivity and muscle fat fraction and their associations: a secondary analysis of a 6-month randomised controlled trial. BMJ Open. 2024 Sep 28;14(9):e084305. doi: 10.1136/bmjopen-2024-084305.
- Derived from this study: PubMed 38575674Sjoros T, Norha J, Johansson R, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Tiredness after work associates with less leisure-time physical activity. Sci Rep. 2024 Apr 4;14(1):7965. doi: 10.1038/s41598-024-58775-4.
- Derived from this study: PubMed 36251378Sjoros T, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Koivumaki M, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Reducing Sedentary Time and Whole-Body Insulin Sensitivity in Metabolic Syndrome: A 6-Month Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Mar 1;55(3):342-353. doi: 10.1249/MSS.0000000000003054. Epub 2022 Oct 13.
- Derived from this study: PubMed 34582633Norha J, Hautala AJ, Sjoros T, Laine S, Garthwaite T, Knuuti J, Loyttyniemi E, Vaha-Ypya H, Sievanen H, Vasankari T, Heinonen IHA. Standing time and daily proportion of sedentary time are associated with pain-related disability in a one month accelerometer measurement in adults with overweight or obesity. Scand J Pain. 2021 Sep 27;22(2):317-324. doi: 10.1515/sjpain-2021-0108. Print 2022 Apr 26.
- Derived from this study: PubMed 33239818Sjoros T, Vaha-Ypya H, Laine S, Garthwaite T, Lahesmaa M, Laurila SM, Latva-Rasku A, Savolainen A, Miikkulainen A, Loyttyniemi E, Sievanen H, Kalliokoski KK, Knuuti J, Vasankari T, Heinonen IHA. Both sedentary time and physical activity are associated with cardiometabolic health in overweight adults in a 1 month accelerometer measurement. Sci Rep. 2020 Nov 25;10(1):20578. doi: 10.1038/s41598-020-77637-3.
- Individual participant dataSharing planned: Undecided. IPD of the main outcome measures will be opened if possible.
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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.
Juhani Knuuti, Professor study chair
Turku PET Centre, Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced sitting in people with Metabolic Syndrome and Physical Activity, run by Turku University Hospital at 1 site in Finland.
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 6 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 8 Apr 2020. 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 Finland. 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?
The change in whole-body insulin sensitivity (time frame: The change from baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT03101228, which also lists 9 linked publications.
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 8 Apr 2020.