search
Back to results

Medical and Physiological Benefits of Reduced Sitting

Primary Purpose

Metabolic Syndrome, Physical Activity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Reduced sitting
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Physical Activity, Metabolic Syndrome, Insulin Sensitivity, Cardiovascular Risk Factor, Sedentary Lifestyle, Accelerometry

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Turku PET Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reduced sitting

Control

Arm Description

Objectively measured daily inactive time will be reduced by one hour compared to the baseline.

Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits.

Outcomes

Primary Outcome Measures

The change in whole-body insulin sensitivity
M-value during the hyperinsulinemic euglycemic clamp
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

Secondary Outcome Measures

daily sitting hours
Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer
daily hours spent physically active
Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer
The change in liver adiposity
Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)
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 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 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 in plasma glucose
Plasma glucose content will be measured from fasting venous blood samples using standard assays
The change in plasma glucose
Plasma glucose content will be measured from fasting venous blood samples using standard assays
The change in HbA1c
Glycated hemoglobin will be measured from fasting venous blood samples using standard assays
The change in HbA1c
Glycated hemoglobin will be measured from fasting venous blood samples using standard assays

Full Information

First Posted
March 24, 2017
Last Updated
April 7, 2020
Sponsor
Turku University Hospital
Collaborators
UKK Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03101228
Brief Title
Medical and Physiological Benefits of Reduced Sitting
Official Title
Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
UKK Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Physical Activity, Insulin Resistance, Cardiovascular Diseases
Keywords
Physical Activity, Metabolic Syndrome, Insulin Sensitivity, Cardiovascular Risk Factor, Sedentary Lifestyle, Accelerometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel-group randomised controlled trial
Masking
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.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced sitting
Arm Type
Experimental
Arm Description
Objectively measured daily inactive time will be reduced by one hour compared to the baseline.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits.
Intervention Type
Behavioral
Intervention Name(s)
Reduced sitting
Intervention Description
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 Outcome Measure Information:
Title
The change in whole-body insulin sensitivity
Description
M-value during the hyperinsulinemic euglycemic clamp
Time Frame
The change from baseline to 6 months
Title
The change in skeletal muscle insulin-stimulated glucose uptake
Description
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
Time Frame
The change from baseline to 6 months
Secondary Outcome Measure Information:
Title
daily sitting hours
Description
Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer
Time Frame
through study completion, an average of 6 months
Title
daily hours spent physically active
Description
Accelerometry data will be collected during the whole intervention period by a triaxial hip-mounted accelerometer
Time Frame
through study completion, an average of 6 months
Title
The change in liver adiposity
Description
Liver fat content will be assessed using magnetic resonance spectroscopy (MRS)
Time Frame
The change from baseline to 6 months
Title
The change in maximal oxygen uptake
Description
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.
Time Frame
The change from baseline to 6 months
Title
The change in body fat percentage
Description
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.
Time Frame
The change from baseline to 3 months
Title
The change in body fat percentage
Description
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.
Time Frame
The change from baseline to 6 months
Title
The change in plasma glucose
Description
Plasma glucose content will be measured from fasting venous blood samples using standard assays
Time Frame
The change from baseline to 3 months
Title
The change in plasma glucose
Description
Plasma glucose content will be measured from fasting venous blood samples using standard assays
Time Frame
The change from baseline to 6 months
Title
The change in HbA1c
Description
Glycated hemoglobin will be measured from fasting venous blood samples using standard assays
Time Frame
The change from baseline to 3 months
Title
The change in HbA1c
Description
Glycated hemoglobin will be measured from fasting venous blood samples using standard assays
Time Frame
The change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juhani Knuuti, Professor
Organizational Affiliation
Turku PET Centre, Turku University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Turku PET Centre
City
Turku
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD of the main outcome measures will be opened if possible.
Citations:
PubMed Identifier
34582633
Citation
Norha J, Hautala AJ, Sjoros T, Laine S, Garthwaite T, Knuuti J, Loyttyniemi E, Vaha-Ypya H, Sievanen H, Vasankari T, Heinonen IHA. Standing time and daily proportion of sedentary time are associated with pain-related disability in a one month accelerometer measurement in adults with overweight or obesity. Scand J Pain. 2021 Sep 27;22(2):317-324. doi: 10.1515/sjpain-2021-0108. Print 2022 Apr 26.
Results Reference
derived
PubMed Identifier
33239818
Citation
Sjoros T, Vaha-Ypya H, Laine S, Garthwaite T, Lahesmaa M, Laurila SM, Latva-Rasku A, Savolainen A, Miikkulainen A, Loyttyniemi E, Sievanen H, Kalliokoski KK, Knuuti J, Vasankari T, Heinonen IHA. Both sedentary time and physical activity are associated with cardiometabolic health in overweight adults in a 1 month accelerometer measurement. Sci Rep. 2020 Nov 25;10(1):20578. doi: 10.1038/s41598-020-77637-3.
Results Reference
derived

Learn more about this trial

Medical and Physiological Benefits of Reduced Sitting

We'll reach out to this number within 24 hrs