Clinical trial NCT02371239: SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
Official title: SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Glucose regulation
Glucose
Lipids
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2015-02-25
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Mean 24 hour glucose concentration
timeFrame: during the last 24 hours of an activity regime
Secondary outcomes:
measure: Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)
timeFrame: during the last 24 hours of an activity regime
measure: Mean 24 hour glucose concentration
timeFrame: during a whole activity regime
measure: Total duration of hyperglycaemia (glucose > 10 mmol/L)
timeFrame: during a whole activity regime
measure: Area under the curve of hyperglycaemia (glucose > 10 mmol/L)
timeFrame: during the last 24 hours of an activity regime
measure: Glucose variability measured as SD divided by mean
timeFrame: the last 24 hours of each regime
measure: Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)
timeFrame: during a whole activity regime
measure: Fasting total cholesterol
timeFrame: one day after each activity regime
measure: Non-HDL cholesterol
timeFrame: one day after each activity regime
measure: HDL cholesterol
timeFrame: one day after each activity regime
measure: LDL cholesterol
timeFrame: one day after each activity regime
measure: Triglycerides
timeFrame: one day after each activity regime
measure: Apolipoprotein B
timeFrame: one day after each activity regime
measure: Apolipoprotein A
timeFrame: one day after each activity regime
measure: Free fatty acids
timeFrame: one day after each activity regime
measure: Fasting glucose
timeFrame: one day after each activity regime
measure: Fasting insulin
timeFrame: one day after each activity regime
measure: Fasting C-peptide
timeFrame: one day after each activity regime
measure: Fasting CRP
timeFrame: one day after each activity regime
measure: Fasting IL-6
timeFrame: one day after each activity regime
measure: Fasting IL-1
timeFrame: one day after each activity regime
measure: Homeostatic model assessment 2 (HOMA2)
timeFrame: one day after each activity regime
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Human Movement Science, Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University Hospital
name: Nicolaas C Schaper, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.