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Medical and Physiological Benefits of Reduced Sitting

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ClinicalTrials.gov Identifier: NCT03101228
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
UKK Institute
Information provided by (Responsible Party):
Ilkka Heinonen, University of Turku

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Physical Activity Insulin Resistance Cardiovascular Diseases Behavioral: Reduced sitting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A parallel-group randomised controlled trial
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.
Primary Purpose: Prevention
Official Title: Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Experimental: Reduced sitting
Objectively measured daily inactive time will be reduced by one hour compared to the baseline.
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.

No Intervention: Control
Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101228


Contacts
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Contact: Ilkka HA Heinonen, PhD +35823138145 ilkka.heinonen@utu.fi

Locations
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Finland
Turku PET Centre Recruiting
Turku, Finland, 20521
Contact: Ilkka H Heinonen, PhD       ilkka.heinonen@utu.fi   
Sponsors and Collaborators
Turku University Hospital
UKK Institute
Investigators
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Study Chair: Juhani Knuuti, Professor Turku PET Centre, Turku University Hospital

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Responsible Party: Ilkka Heinonen, Principal Investigator, University of Turku
ClinicalTrials.gov Identifier: NCT03101228     History of Changes
Other Study ID Numbers: T91/2017
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD of the main outcome measures will be opened if possible.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilkka Heinonen, University of Turku:
Physical Activity
Metabolic Syndrome
Insulin Sensitivity
Cardiovascular Risk Factor
Sedentary Lifestyle
Accelerometry

Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases