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NCT Number: NCT02371239

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Movement Science, Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical activity intervention

Behavioral

Primary outcomes

  1. Mean 24 hour glucose concentration

    Time frame: during the last 24 hours of an activity regime

Secondary outcomes

  1. Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)

    Time frame: during the last 24 hours of an activity regime

  2. Mean 24 hour glucose concentration

    Time frame: during a whole activity regime

  3. Total duration of hyperglycaemia (glucose > 10 mmol/L)

    Time frame: during a whole activity regime

  4. Area under the curve of hyperglycaemia (glucose > 10 mmol/L)

    Time frame: during the last 24 hours of an activity regime

  5. Glucose variability measured as SD divided by mean

    Time frame: the last 24 hours of each regime

  6. Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)

    Time frame: during a whole activity regime

  7. Fasting total cholesterol

    Time frame: one day after each activity regime

  8. Non-HDL cholesterol

    Time frame: one day after each activity regime

  9. HDL cholesterol

    Time frame: one day after each activity regime

  10. LDL cholesterol

    Time frame: one day after each activity regime

  11. Triglycerides

    Time frame: one day after each activity regime

  12. Apolipoprotein B

    Time frame: one day after each activity regime

  13. Apolipoprotein A

    Time frame: one day after each activity regime

  14. Free fatty acids

    Time frame: one day after each activity regime

  15. Fasting glucose

    Time frame: one day after each activity regime

  16. Fasting insulin

    Time frame: one day after each activity regime

  17. Fasting C-peptide

    Time frame: one day after each activity regime

  18. Fasting CRP

    Time frame: one day after each activity regime

  19. Fasting IL-6

    Time frame: one day after each activity regime

  20. Fasting IL-1

    Time frame: one day after each activity regime

  21. Homeostatic model assessment 2 (HOMA2)

    Time frame: one day after each activity regime

    to assess insulin sensitivity

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Acronym: SIT LESS 2

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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