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SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2

SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02371239
Acronym
SIT LESS 2
Enrollment
19
Registered
2015-02-25
Start date
2015-02-28
Completion date
2015-05-31
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Glucose regulation, Glucose, Lipids

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.

Interventions

BEHAVIORALPhysical activity intervention

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean 24 hour glucose concentrationduring the last 24 hours of an activity regime

Secondary

MeasureTime frameDescription
Mean 24 hour glucose concentrationduring a whole activity regime
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 meanthe last 24 hours of each regime
Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)during a whole activity regime
Fasting total cholesterolone day after each activity regime
Non-HDL cholesterolone day after each activity regime
HDL cholesterolone day after each activity regime
LDL cholesterolone day after each activity regime
Triglyceridesone day after each activity regime
Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)during the last 24 hours of an activity regime
Apolipoprotein Aone day after each activity regime
Free fatty acidsone day after each activity regime
Fasting glucoseone day after each activity regime
Fasting insulinone day after each activity regime
Fasting C-peptideone day after each activity regime
Fasting CRPone day after each activity regime
Fasting IL-6one day after each activity regime
Fasting IL-1one day after each activity regime
Homeostatic model assessment 2 (HOMA2)one day after each activity regimeto assess insulin sensitivity
Apolipoprotein Bone day after each activity regime

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026