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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03101228
Date of registration: 24/03/2017
Prospective Registration: Yes
Primary sponsor: Turku University Hospital
Public title: Medical and Physiological Benefits of Reduced Sitting
Scientific title: Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
Date of first enrolment: April 25, 2017
Target sample size: 64
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03101228
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Finland
Contacts
Name:     Juhani Knuuti, Professor
Address: 
Telephone:
Email:
Affiliation:  Turku PET Centre, Turku University Hospital
Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Physical Activity
Metabolic Syndrome
Cardiovascular Diseases
Insulin Resistance
Intervention(s)
Behavioral: Reduced sitting
Primary Outcome(s)
The change in skeletal muscle insulin-stimulated glucose uptake [Time Frame: The change from baseline to 6 months]
The change in whole-body insulin sensitivity [Time Frame: The change from baseline to 6 months]
Secondary Outcome(s)
daily hours spent physically active [Time Frame: through study completion, an average of 6 months]
The change in maximal oxygen uptake [Time Frame: The change from baseline to 6 months]
The change in body fat percentage [Time Frame: The change from baseline to 6 months]
The change in plasma glucose [Time Frame: The change from baseline to 3 months]
daily sitting hours [Time Frame: through study completion, an average of 6 months]
The change in plasma glucose [Time Frame: The change from baseline to 6 months]
The change in liver adiposity [Time Frame: The change from baseline to 6 months]
The change in body fat percentage [Time Frame: The change from baseline to 3 months]
The change in HbA1c [Time Frame: The change from baseline to 3 months]
The change in HbA1c [Time Frame: The change from baseline to 6 months]
Secondary ID(s)
T91/2017
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
UKK Institute
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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