Medical and Physiological Benefits of Reduced Sitting

Not Applicable

Completed

• Conditions: Physical Activity; Insulin Resistance; Metabolic Syndrome; Cardiovascular Diseases
• Interventions: Behavioral: Reduced sitting

• Registration Number: NCT03101228
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Study Start: 2017-04-25
• Primary Completion: 2020-02-14
• Study Completion: 2020-03-04
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced sitting	Reduced sitting	Objectively measured daily inactive time will be reduced by one hour compared to the baseline.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
The change in plasma glucose	The change from baseline to 6 months	Plasma glucose content will be measured from fasting venous blood samples using standard assays
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
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 body fat percentage	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.
The change in HbA1c	The change from baseline to 6 months	Glycated hemoglobin will be measured from fasting venous blood samples using standard assays
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

Trial Locations

Locations (1)

Turku PET Centre; 🇫🇮 Turku, Finland