Overweight and Obesity
Conditions
Brief summary
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
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy * No engagement in habitual structured physical activity * Body mass index 25-35 kg/m2 * Body fat percentage \>32% for women and \>25% for men * Maximum oxygen uptake (VO2max) \<40 ml O2/kg/min for women and \<45 ml O2/kg/min for men * Ethnicity: Caucasian
Exclusion criteria
* Chronic use of medicine * Smoking * Fasting plasma glucose \> 6,1 mmol/L * Blood pressure \> 140/90 mm Hg * Abnormal resting and working ECG * Parents or siblings with diagnosed type 2 diabetes * For women: Follicle stimulating hormone (FSH) concentration \> 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemostatic balance | Change from baseline in endogenous thrombin potential at 3 months | Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min) |
| Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin) | Change from baseline in peripheral insulin sensitivity at 3 months | Measured using the hyper-insulinemic euglycaemic clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central insulin sensitivity | Baseline, 3 and 6 months | Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test |
| Maximal oxygen uptake (ml/O2/kg/min) | Baseline, 3 and 6 months | Measured using indirect calorimetry and an incremental bicycle protocol |
| Abdominal fat mass | Baseline, 3 and 6 months | Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging |
| Metabolic syndrome | Baseline, 3 and 6 months | As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores |
| Haemostatic balance II | Baseline, 3 and 6 months | 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. |
| Anthropometry | Baseline, 3 and 6 months | Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height |
| Sleep habits | Baseline, 3 and 6 months | Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale) |
| Skeletal muscle biopsy | Baseline, 3 and 6 months | Biochemical, proteomics, metabolomics, genomics and morphological analyses |
| Subcutaneous adipose tissue biopsy | Baseline, 3 and 6 months | Biochemical, proteomics, metabolomics, genomics and morphological analyses |
| Health related quality of life and other psycho-social outcomes | Baseline, 3 and 6 months | Measured using questionaries (SF-36), semi-structured interviews and observations |
| Glycaemic control | Baseline, 3 and 6 months | Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise compliance | Baseline, 3 and 6 month | Adherence to the exercise protocol as measured using heart rate and global positioning system monitors will be assessed and individually adjusted continuously over the course of the exercise intervention |
Countries
Denmark