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

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ClinicalTrials.gov Identifier: NCT02371239
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Physical activity intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
Study Start Date : February 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitting regime
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.
Behavioral: Physical activity intervention
Experimental: Sit Less regime
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.
Behavioral: Physical activity intervention
Experimental: Exercise regime
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.
Behavioral: Physical activity intervention



Primary Outcome Measures :
  1. Mean 24 hour glucose concentration [ Time Frame: during the last 24 hours of an activity regime ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371239


Locations
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Netherlands
Human Movement Science, Maastricht University
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Novo Nordisk A/S
Investigators
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Principal Investigator: Nicolaas C Schaper, MD PhD Maastricht University Hospital
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02371239    
Other Study ID Numbers: 13-2-050
NL45498.068.13 ( Registry Identifier: Medical Ethical Committee Maastricht University Hospital / University of Maastricht )
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Maastricht University Medical Center:
Glucose regulation
Glucose
Lipids
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases