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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Physical activity intervention

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Human Movement Science, Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean 24 hour glucose concentration	during the last 24 hours of an activity regime

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)		during the last 24 hours of an activity regime
Mean 24 hour glucose concentration		during 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 mean		the last 24 hours of each regime
Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)		during a whole activity regime
Fasting total cholesterol		one day after each activity regime
Non-HDL cholesterol		one day after each activity regime
HDL cholesterol		one day after each activity regime
LDL cholesterol		one day after each activity regime
Triglycerides		one day after each activity regime
Apolipoprotein B		one day after each activity regime
Apolipoprotein A		one day after each activity regime
Free fatty acids		one day after each activity regime
Fasting glucose		one day after each activity regime
Fasting insulin		one day after each activity regime
Fasting C-peptide		one day after each activity regime
Fasting CRP		one day after each activity regime
Fasting IL-6		one day after each activity regime
Fasting IL-1		one day after each activity regime
Homeostatic model assessment 2 (HOMA2)	to assess insulin sensitivity	one day after each activity regime

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Nicolaas C Schaper, MD PhD, Maastricht University Hospital

Publications and helpful links

General Publications

• 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. Erratum In: PLoS One. 2014;9(8):e105135.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Lipids; Glucose regulation; Glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 13-2-050; NL45498.068.13 (Registry Identifier: Medical Ethical Committee Maastricht University Hospital / University of Maastricht)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No