Medical and Physiological Benefits of Reduced Sitting

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101228
• Other study ID #: T91/2017
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: March 4, 2020

Study information

• Verified date: April 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 4, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Insulin Resistance
• Metabolic Syndrome
• Physical Activity

Intervention

Behavioral:
• Reduced 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.

Locations

Country	Name	City	State
Finland	Turku PET Centre	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	UKK Institute

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in whole-body insulin sensitivity	M-value during the hyperinsulinemic euglycemic clamp	The change from baseline to 6 months
Primary	The change in skeletal muscle insulin-stimulated glucose uptake	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	The change from baseline to 6 months
Secondary	daily sitting hours	Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer	through study completion, an average of 6 months
Secondary	daily hours spent physically active	Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer	through study completion, an average of 6 months
Secondary	The change in liver adiposity	Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)	The change from baseline to 6 months
Secondary	The change in maximal oxygen uptake	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 from baseline to 6 months
Secondary	The change in body fat percentage	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 from baseline to 3 months
Secondary	The change in body fat percentage	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 from baseline to 6 months
Secondary	The change in plasma glucose	Plasma glucose content will be measured from fasting venous blood samples using standard assays	The change from baseline to 3 months
Secondary	The change in plasma glucose	Plasma glucose content will be measured from fasting venous blood samples using standard assays	The change from baseline to 6 months
Secondary	The change in HbA1c	Glycated hemoglobin will be measured from fasting venous blood samples using standard assays	The change from baseline to 3 months
Secondary	The change in HbA1c	Glycated hemoglobin will be measured from fasting venous blood samples using standard assays	The change from baseline to 6 months