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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE February 25, 2015
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
Mean 24 hour glucose concentration [ Time Frame: during the last 24 hours of an activity regime ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L) [ Time Frame: during the last 24 hours of an activity regime ]
  • Mean 24 hour glucose concentration [ Time Frame: during a whole activity regime ]
  • Total duration of hyperglycaemia (glucose > 10 mmol/L) [ Time Frame: during a whole activity regime ]
  • Area under the curve of hyperglycaemia (glucose > 10 mmol/L) [ Time Frame: during the last 24 hours of an activity regime ]
  • Glucose variability measured as SD divided by mean [ Time Frame: the last 24 hours of each regime ]
  • Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L) [ Time Frame: during a whole activity regime ]
  • Fasting total cholesterol [ Time Frame: one day after each activity regime ]
  • Non-HDL cholesterol [ Time Frame: one day after each activity regime ]
  • HDL cholesterol [ Time Frame: one day after each activity regime ]
  • LDL cholesterol [ Time Frame: one day after each activity regime ]
  • Triglycerides [ Time Frame: one day after each activity regime ]
  • Apolipoprotein B [ Time Frame: one day after each activity regime ]
  • Apolipoprotein A [ Time Frame: one day after each activity regime ]
  • Free fatty acids [ Time Frame: one day after each activity regime ]
  • Fasting glucose [ Time Frame: one day after each activity regime ]
  • Fasting insulin [ Time Frame: one day after each activity regime ]
  • Fasting C-peptide [ Time Frame: one day after each activity regime ]
  • Fasting CRP [ Time Frame: one day after each activity regime ]
  • Fasting IL-6 [ Time Frame: one day after each activity regime ]
  • Fasting IL-1 [ Time Frame: one day after each activity regime ]
  • Homeostatic model assessment 2 (HOMA2) [ Time Frame: one day after each activity regime ]
    to assess insulin sensitivity
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
  • Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L) [ Time Frame: during the last 24 hours of an activity regime ]
  • Mean 24 hour glucose concentration [ Time Frame: during a whole activity regime ]
  • Total duration of hyperglycaemia (glucose > 10 mmol/L) [ Time Frame: during a whole activity regime ]
  • Area under the curve of hyperglycaemia (glucose > 10 mmol/L) [ Time Frame: during the last 24 hours of an activity regime ]
  • Glucose variability measured as SD divided by mean [ Time Frame: the last 24 hours of each regime ]
  • Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L) [ Time Frame: during a whole activity regime ]
  • Fasting total cholesterol [ Time Frame: one day after each activity regime ]
  • Non-HDL cholesterol [ Time Frame: one day after each activity regime ]
  • HDL cholesterol [ Time Frame: one day after each activity regime ]
  • LDL cholesterol [ Time Frame: one day after each activity regime ]
  • Triglycerides [ Time Frame: one day after each activity regime ]
  • Apolipoprotein B [ Time Frame: one day after each activity regime ]
  • Apolipoprotein A [ Time Frame: one day after each activity regime ]
  • Free fatty acids [ Time Frame: one day after each activity regime ]
  • Fasting glucose [ Time Frame: one day after each activity regime ]
  • Fasting insulin [ Time Frame: one day after each activity regime ]
  • Fasting C-peptide [ Time Frame: one day after each activity regime ]
  • Fasting CRP [ Time Frame: one day after each activity regime ]
  • Fasting IL-6 [ Time Frame: one day after each activity regime ]
  • Fasting IL-1 [ Time Frame: one day after each activity regime ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
Official Title  ICMJE SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Behavioral: Physical activity intervention
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Behavioral: Physical activity intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2015)
19
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2015)
24
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02371239
Other Study ID Numbers  ICMJE 13-2-050
NL45498.068.13 ( Registry Identifier: Medical Ethical Committee Maastricht University Hospital / University of Maastricht )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Nicolaas C Schaper, MD PhD Maastricht University Hospital
PRS Account Maastricht University Medical Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP