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

Type 2 Diabetes Clinical Trial

— SIT LESS 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371239
• Other study ID #: 13-2-050
• Secondary ID: NL45498.068.13
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: March 15, 2016
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Physical activity intervention

Locations

Country	Name	City	State
Netherlands	Human Movement Science, Maastricht University	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24 hour glucose concentration		during the last 24 hours of an activity regime	No
Secondary	Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)		during the last 24 hours of an activity regime	Yes
Secondary	Mean 24 hour glucose concentration		during a whole activity regime	No
Secondary	Total duration of hyperglycaemia (glucose > 10 mmol/L)		during a whole activity regime	Yes
Secondary	Area under the curve of hyperglycaemia (glucose > 10 mmol/L)		during the last 24 hours of an activity regime	No
Secondary	Glucose variability measured as SD divided by mean		the last 24 hours of each regime	No
Secondary	Total duration of hypoglycaemia (glucose = 3.9 mmol/L)		during a whole activity regime	Yes
Secondary	Fasting total cholesterol		one day after each activity regime	No
Secondary	Non-HDL cholesterol		one day after each activity regime	No
Secondary	HDL cholesterol		one day after each activity regime	No
Secondary	LDL cholesterol		one day after each activity regime	No
Secondary	Triglycerides		one day after each activity regime	No
Secondary	Apolipoprotein B		one day after each activity regime	No
Secondary	Apolipoprotein A		one day after each activity regime	No
Secondary	Free fatty acids		one day after each activity regime	No
Secondary	Fasting glucose		one day after each activity regime	No
Secondary	Fasting insulin		one day after each activity regime	No
Secondary	Fasting C-peptide		one day after each activity regime	No
Secondary	Fasting CRP		one day after each activity regime	No
Secondary	Fasting IL-6		one day after each activity regime	No
Secondary	Fasting IL-1		one day after each activity regime	No
Secondary	Homeostatic model assessment 2 (HOMA2)	to assess insulin sensitivity	one day after each activity regime	No

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