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| ID | Type | Description | Link |
|---|---|---|---|
| NL45498.068.13 | Registry Identifier | Medical Ethical Committee Maastricht University Hospital / University of Maastricht |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean 24 hour glucose concentration | during the last 24 hours of an activity regime |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L) | during the last 24 hours of an activity regime | |
| Mean 24 hour glucose concentration | during a whole activity regime | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolaas C Schaper, MD PhD | Maastricht University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Movement Science, Maastricht University | Maastricht | Limburg | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23418444 | Background | 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. | |
| 27904925 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Total duration of hyperglycaemia (glucose > 10 mmol/L) |
| during a whole activity regime |
| Area under the curve of hyperglycaemia (glucose > 10 mmol/L) | during the last 24 hours of an activity regime |
| Glucose variability measured as SD divided by mean | the last 24 hours of each regime |
| Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L) | during a whole activity regime |
| Fasting total cholesterol | one day after each activity regime |
| Non-HDL cholesterol | one day after each activity regime |
| HDL cholesterol | one day after each activity regime |
| LDL cholesterol | one day after each activity regime |
| Triglycerides | one day after each activity regime |
| Apolipoprotein B | one day after each activity regime |
| Apolipoprotein A | one day after each activity regime |
| Free fatty acids | one day after each activity regime |
| Fasting glucose | one day after each activity regime |
| Fasting insulin | one day after each activity regime |
| Fasting C-peptide | one day after each activity regime |
| Fasting CRP | one day after each activity regime |
| Fasting IL-6 | one day after each activity regime |
| Fasting IL-1 | one day after each activity regime |
| Homeostatic model assessment 2 (HOMA2) | to assess insulin sensitivity | one day after each activity regime |
| Derived |
| Duvivier 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. |
| D004700 | Endocrine System Diseases |