Type 2 DiabetesSIT LESS 2NCT02371239
SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
A study testing Physical activity intervention in people with Type 2 Diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Introduction: Changes in lifestyle are responsible for an important part of the type 2 diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity (most often physical exercise). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to May 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Men and women: 40-75 years old
- Diabetes mellitus type 2, developed after the age of 40 years old
- Treatment with diet or oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors)
- HbA1c: < 10%
- BMI: 25.0 - 35.0 kg/m2
- Maximum 2.5 hours of MVPA per week (during last 3 months)
- Internet availability on a daily basis
Who cannot join
- Pregnancy or intention of becoming pregnant
- Alcohol use: > 2 units per day (during the last 3 months)
- Experimental drug use (during the last 3 months)
- Use of insulin, corticosteroids, vitamin K antagonists and immunosuppressive drugs in the last 3 months
- Triglyceride level > 10.0 mmol/L
- Fasting plasma glucose level > 10 mmol/L
Show all 19Show fewer
- Heart failure NYHA 3 or higher
- Angina pectoris or signs of cardiac ischemia during exercise testing
- COPD Gold 3 or higher
- Glomerular filtration rate (GFR) < 30 ml/min
- Diagnosis of active cancer (not cancer in the past that is cured)
- Diabetes mellitus type 1
- Intermittent claudication with a walking distance < 500 meter
- Not able to cycle for ± 45 minutes, as judged from the incremental exhaustive exercise bicycle-ergometer test at Visit 1
- Based on historical information not able to walk for 3 hours per day and stand for 4 hours per day
- Mental or physical disability which makes physical activity not possible
- Participation in a clinical trial with medication use (in the last 3 months)
- Severe loss of vision
- Active foot ulcer or venous leg ulcer
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Human Movement Science, Maastricht University
Maastricht, Limburg, 6200 MD
About this study
Introduction: Changes in lifestyle are responsible for an important part of the type 2 diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity (most often physical exercise). Recent studies suggest that sitting has negative metabolic effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).
Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise, LIPA might be a more feasible strategy. But, it remains to be determined whether reducing sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether these effects are independent of the increase in energy expenditure
Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2) who perform no, or only little, exercise and who are treated with diet only or with oral blood glucose lowering medication. They will perform three regimes of each four days: 1) a sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of the exercise regime will be identical to that of the sit less regime. Sitting, walking and standing will be objectively measured by a 24 hour physical activity monitor. The energy spent during exercise will be standardised and quantified by using a bicycle ergometer; energy intake will be standardised as well. During each regime blood glucose will be measured with a 24 hour continuous glucose sensor.
- Conditions
- Type 2 Diabetes
- Being tested
- Physical activity intervention
- Keywords
- Glucose regulation, Glucose, Lipids
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sitting regime | Experimental | The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying. Receives: Behavioral: Physical activity intervention |
| Sit Less regime | Experimental | Subjects will follow the sit less regime during four days. Each day will consist of 3 hours walking, 4 hours standing, 9 hours sitting and 8 hours sleeping or lying. The additional 2 hours of walking and 3 hours of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1 hour. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc. Receives: Behavioral: Physical activity intervention |
| Exercise regime | Experimental | Subjects will follow the exercise regime during four days. Each day will consist of 13 hours and 15 minutes sitting, ± 45 minutes supervised cycling on an ergometer, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying. Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24 hour glucose concentration
Measured: during the last 24 hours of an activity regime
Secondary outcomes (21)
Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)
Measured: during the last 24 hours of an activity regime
Mean 24 hour glucose concentration
Measured: during a whole activity regime
Total duration of hyperglycaemia (glucose > 10 mmol/L)
Measured: during a whole activity regime
Area under the curve of hyperglycaemia (glucose > 10 mmol/L)
Measured: during the last 24 hours of an activity regime
Glucose variability measured as SD divided by mean
Measured: the last 24 hours of each regime
Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)
Measured: during a whole activity regime
Fasting total cholesterol
Measured: one day after each activity regime
Non-HDL cholesterol
Measured: one day after each activity regime
HDL cholesterol
Measured: one day after each activity regime
LDL cholesterol
Measured: one day after each activity regime
Triglycerides
Measured: one day after each activity regime
Apolipoprotein B
Measured: one day after each activity regime
Apolipoprotein A
Measured: one day after each activity regime
Free fatty acids
Measured: one day after each activity regime
Fasting glucose
Measured: one day after each activity regime
Fasting insulin
Measured: one day after each activity regime
Fasting C-peptide
Measured: one day after each activity regime
Fasting CRP
Measured: one day after each activity regime
Fasting IL-6
Measured: one day after each activity regime
Fasting IL-1
Measured: one day after each activity regime
Homeostatic model assessment 2 (HOMA2)
to assess insulin sensitivity
Measured: one day after each activity regime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Nicolaas C Schaper, MD PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371239
- Sponsor's protocol ID
- 13-2-050
- Other IDs
- NL45498.068.13
- Acronym
- SIT LESS 2
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duvivier BM, Schaper NC, Bremers MA, van Crombrugge G, Menheere PP, Kars M, Savelberg HH. Minimal intensity physical activity (standing and walking) of longer duration improves insulin action and plasma lipids more than shorter periods of moderate to vigorous exercise (cycling) in sedentary subjects when energy expenditure is comparable. PLoS One. 2013;8(2):e55542. doi: 10.1371/journal.pone.0055542. Epub 2013 Feb 13.
PubMed 23418444Duvivier BM, Schaper NC, Hesselink MK, van Kan L, Stienen N, Winkens B, Koster A, Savelberg HH. Breaking sitting with light activities vs structured exercise: a randomised crossover study demonstrating benefits for glycaemic control and insulin sensitivity in type 2 diabetes. Diabetologia. 2017 Mar;60(3):490-498. doi: 10.1007/s00125-016-4161-7. Epub 2016 Nov 30.
PubMed 27904925
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT02371239
- Acronym / sponsor ID
- SIT LESS 2 / 13-2-050
- Conditions
- Type 2 Diabetes
- Keywords
- Glucose regulation, Glucose, Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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.
Introduction: Changes in lifestyle are responsible for an important part of the type 2 diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity (most often physical exercise). Recent studies suggest that sitting has negative metabolic effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).
Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise, LIPA might be a more feasible strategy. But, it remains to be determined whether reducing sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether these effects are independent of the increase in energy expenditure
Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2) who perform no, or only little, exercise and who are treated with diet only or with oral blood glucose lowering medication. They will perform three regimes of each four days: 1) a sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of the exercise regime will be identical to that of the sit less regime. Sitting, walking and standing will be objectively measured by a 24 hour physical activity monitor. The energy spent during exercise will be standardised and quantified by using a bicycle ergometer; energy intake will be standardised as well. During each regime blood glucose will be measured with a 24 hour continuous glucose sensor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitting regime | Experimental | Behavioral: Physical activity interventionThe subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying. |
| Sit Less regime | Experimental | Behavioral: Physical activity interventionSubjects will follow the sit less regime during four days. Each day will consist of 3 hours walking, 4 hours standing, 9 hours sitting and 8 hours sleeping or lying. The additional 2 hours of walking and 3 hours of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1 hour. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc. |
| Exercise regime | Experimental | Behavioral: Physical activity interventionSubjects will follow the exercise regime during four days. Each day will consist of 13 hours and 15 minutes sitting, ± 45 minutes supervised cycling on an ergometer, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Men and women: 40-75 years old
- Diabetes mellitus type 2, developed after the age of 40 years old
- Treatment with diet or oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors)
- HbA1c: < 10%
Key exclusion criteria (19 listed)
- Pregnancy or intention of becoming pregnant
- Alcohol use: > 2 units per day (during the last 3 months)
- Experimental drug use (during the last 3 months)
- Use of insulin, corticosteroids, vitamin K antagonists and immunosuppressive drugs in the last 3 months
- Triglyceride level > 10.0 mmol/L
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 |
|---|---|---|
| Physical activity intervention | Behavioural | Exercise regime, Sit Less regime, Sitting regime |
Primary outcome
Mean 24 hour glucose concentration
Time frame: during the last 24 hours of an activity regime
21 secondary outcomes
Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)
Time frame: during the last 24 hours of an activity regime
Mean 24 hour glucose concentration
Time frame: during a whole activity regime
Total duration of hyperglycaemia (glucose > 10 mmol/L)
Time frame: during a whole activity regime
Area under the curve of hyperglycaemia (glucose > 10 mmol/L)
Time frame: during the last 24 hours of an activity regime
Glucose variability measured as SD divided by mean
Time frame: the last 24 hours of each regime
Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)
Time frame: during a whole activity regime
Fasting total cholesterol
Time frame: one day after each activity regime
Non-HDL cholesterol
Time frame: one day after each activity regime
HDL cholesterol
Time frame: one day after each activity regime
LDL cholesterol
Time frame: one day after each activity regime
Triglycerides
Time frame: one day after each activity regime
Apolipoprotein B
Time frame: one day after each activity regime
Apolipoprotein A
Time frame: one day after each activity regime
Free fatty acids
Time frame: one day after each activity regime
Fasting glucose
Time frame: one day after each activity regime
Fasting insulin
Time frame: one day after each activity regime
Fasting C-peptide
Time frame: one day after each activity regime
Fasting CRP
Time frame: one day after each activity regime
Fasting IL-6
Time frame: one day after each activity regime
Fasting IL-1
Time frame: one day after each activity regime
Homeostatic model assessment 2 (HOMA2)
Time frame: one day after each activity regime
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 16 Mar 2016.
- Background: PubMed 23418444Duvivier BM, Schaper NC, Bremers MA, van Crombrugge G, Menheere PP, Kars M, Savelberg HH. Minimal intensity physical activity (standing and walking) of longer duration improves insulin action and plasma lipids more than shorter periods of moderate to vigorous exercise (cycling) in sedentary subjects when energy expenditure is comparable. PLoS One. 2013;8(2):e55542. doi: 10.1371/journal.pone.0055542. Epub 2013 Feb 13.
- Derived from this study: PubMed 27904925Duvivier BM, Schaper NC, Hesselink MK, van Kan L, Stienen N, Winkens B, Koster A, Savelberg HH. Breaking sitting with light activities vs structured exercise: a randomised crossover study demonstrating benefits for glycaemic control and insulin sensitivity in type 2 diabetes. Diabetologia. 2017 Mar;60(3):490-498. doi: 10.1007/s00125-016-4161-7. Epub 2016 Nov 30.
- Related InfoLink provided by the sponsor.
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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.
Nicolaas C Schaper, MD PhD principal investigator
Maastricht 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 Physical activity intervention in people with Type 2 Diabetes, 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 8 inclusion and 19 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 16 Mar 2016. 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?
Mean 24 hour glucose concentration (time frame: during the last 24 hours of an activity regime). 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 NCT02371239, which also lists 2 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 16 Mar 2016.