Skip to main content
OpenTrials
Completed

NCT Number: NCT03101228

Medical and Physiological Benefits of Reduced Sitting

The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Behavior Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Activity Sedentary Behavior

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku PET Centre

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
  • Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
  • BMI 25-40
  • Blood pressure < 160/100 mmHg
  • Fasting plasma glucose < 7.0 mmol/l
  • Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009

Exclusion criteria

  • History of a cardiac event
  • Insulin or medically treated diabetes
  • Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
  • Presence of ferromagnetic objects that would make MR imaging contraindicated
  • Abundant use of alcohol
  • Use of narcotics
  • Smoking of tobacco or consuming snuff tobacco
  • Diagnosed depressive or bipolar disorder
  • Previous PET imaging or considerable exposure to radiation

Treatment and study plan

Reduced sitting

Behavioral

Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.

Primary outcomes

  1. The change in whole-body insulin sensitivity

    Time frame: The change from baseline to 6 months

    M-value during the hyperinsulinemic euglycemic clamp

  2. The change in skeletal muscle insulin-stimulated glucose uptake

    Time frame: The change from baseline to 6 months

    Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with [18F]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp

Secondary outcomes

  1. daily sitting hours

    Time frame: through study completion, an average of 6 months

    Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer

  2. daily hours spent physically active

    Time frame: through study completion, an average of 6 months

    Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer

  3. The change in liver adiposity

    Time frame: The change from baseline to 6 months

    Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)

  4. The change in maximal oxygen uptake

    Time frame: The change from baseline to 6 months

    Maximal oxygen uptake (VO2peak) will be determined by cycle ergometry with direct respiratory measurements. Exercise intensity will be started at 50 W and the intensity will be increased by 25 W at every two minutes until the criteria used to establish the VO2peak are met. The criteria used to establish the VO2peak are a plateau in VO2 despite of an increase in intensity and a respiratory quotient greater than 1.1. or volitional fatigue.

  5. The change in body fat percentage

    Time frame: The change from baseline to 3 months

    Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.

  6. The change in body fat percentage

    Time frame: The change from baseline to 6 months

    Air displacement plethysmography (the Bod Pod system, COSMED, Inc., Concord, CA, USA) will be used to measure body composition (fat mass and fat free mass) with thoracic gas volume being predicted.

  7. The change in plasma glucose

    Time frame: The change from baseline to 3 months

    Plasma glucose content will be measured from fasting venous blood samples using standard assays

  8. The change in plasma glucose

    Time frame: The change from baseline to 6 months

    Plasma glucose content will be measured from fasting venous blood samples using standard assays

  9. The change in HbA1c

    Time frame: The change from baseline to 3 months

    Glycated hemoglobin will be measured from fasting venous blood samples using standard assays

  10. The change in HbA1c

    Time frame: The change from baseline to 6 months

    Glycated hemoglobin will be measured from fasting venous blood samples using standard assays

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • UKK Institute

Registry information

Official study title

Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2017
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.