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

NCT02371239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-03-16

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Physical activity intervention

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Nicolaas C Schaper, MD PhD · Maastricht University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371239 on ClinicalTrials.gov