The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals. Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
188
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, Denmark
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Measured using the hyper-insulinemic euglycaemic clamp
Time frame: Change from baseline in peripheral insulin sensitivity at 3 months
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Measured using the hyper-insulinemic euglycaemic clamp
Time frame: Change from baseline in peripheral insulin sensitivity at 6 months
Haemostatic balance
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Time frame: Change from baseline in endogenous thrombin potential at 3 months
Haemostatic balance
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Time frame: Change from baseline in endogenous thrombin potential at 6 months
Glycaemic control
Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test
Time frame: Baseline, 3 and 6 months
Central insulin sensitivity
Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Time frame: Baseline, 3 and 6 months
Maximal oxygen uptake (ml/O2/kg/min)
Measured using indirect calorimetry and an incremental bicycle protocol
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Time frame: Baseline, 3 and 6 months
Abdominal fat mass
Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Time frame: Baseline, 3 and 6 months
Metabolic syndrome
As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Time frame: Baseline, 3 and 6 months
Haemostatic balance II
1: Coagulation: Fibrinogen, Tissue factor(TF), prothrombin fragment 1+2. 2: Fibrinolysis: Tissue type plasminogen activator(tPA:AG), Plasminogen activator inhibitor type 1(PAI-1:AG). 3: Endothelial cell function: von Willebrand factor(vWF), Tissue factor pathway inhibitor (TFPI). 4: Inflammation: C-Reactive protein.
Time frame: Baseline, 3 and 6 months
Health related quality of life and other psycho-social outcomes
Measured using questionaries (SF-36), semi-structured interviews and observations
Time frame: Baseline, 3 and 6 months
Anthropometry
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Time frame: Baseline, 3 and 6 months
Sleep habits
Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
Time frame: Baseline, 3 and 6 months
Skeletal muscle biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time frame: Baseline, 3 and 6 months
Subcutaneous adipose tissue biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time frame: Baseline, 3 and 6 months