Cardiovascular Diseases, Insulin Resistance, Metabolic Syndrome, Physical Activity
Conditions
Keywords
Physical Activity, Metabolic Syndrome, Insulin Sensitivity, Cardiovascular Risk Factor, Sedentary Lifestyle, Accelerometry
Brief summary
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.
Interventions
BEHAVIORALReduced sitting
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.
Sponsors
UKK Institute
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, masking of the participants is not possible. Analyzing of the obtained data will be masked.
Intervention model description
A parallel-group randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in whole-body insulin sensitivity | The change from baseline to 6 months | M-value during the hyperinsulinemic euglycemic clamp |
| The change in skeletal muscle insulin-stimulated glucose uptake | 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
| Measure | Time frame | Description |
|---|---|---|
| The change in liver adiposity | The change from baseline to 6 months | Liver fat content will be assessed using magnetic resonance spectroscopy (MRS) |
| The change in maximal oxygen uptake | 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. |
| daily sitting hours | through study completion, an average of 6 months | Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer |
| The change in plasma glucose | The change from baseline to 3 months | Plasma glucose content will be measured from fasting venous blood samples using standard assays |
| The change in HbA1c | The change from baseline to 3 months | Glycated hemoglobin will be measured from fasting venous blood samples using standard assays |
| The change in body fat percentage | 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. |
| daily hours spent physically active | through study completion, an average of 6 months | Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer |
Countries
Finland
Outcome results
None listed