Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in insulin sensitivity
Study Overview
Brief Summary
The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.
Detailed Description
At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests:
- Cardio respiratory fitness
- blood pressure
- anthropometric measures
At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity.
Tissue and blood samples were also collected for further analysis:
- Total-protein analysis of selected proteins
- Fasting plasma glucose, insulin and free fatty acids
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overweight (body mass index 25-30 kg/m2)
- •Weight stable (±2 kg during the past 6 months)
- •Body fat% >25%,
- •Maximal oxygen uptake <45 mL/min/kg
- •Sedentary and healthy according to interview
- •Fasting glucose <6.1 mmol/L
- •Blood pressure <140/90 mmHg
- •No first degree relatives with type-2-diabetes
Exclusion Criteria
- •Resistance training
- •Inability to meet intervention criteria
Arms & Interventions
Physical training, unchanged diet
Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet
Intervention: 12 weeks of lifestyle change (Behavioral)
Physical training, increased diet
Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.
Intervention: 12 weeks of lifestyle change (Behavioral)
Diet, unchanged physical activity
Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle
Intervention: 12 weeks of lifestyle change (Behavioral)
Control
Unchanged sedentary lifestyle and diet
Intervention: 12 weeks of lifestyle change (Behavioral)
Outcomes
Primary Outcomes
Change in insulin sensitivity
Time Frame: week 0 and 13
Before and after the 12 week interventions a 1-step, 120 min, hyperinsulinaemic, euglycemic clamp was performed. After an initial 2mL bolus of insulin infusate, insulin was infused at 40 microU/min/kg.
Secondary Outcomes
- Changes in body composition(DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13)
