Physical Training Per se (TPS)

University of Copenhagen

Status: Completed

Conditions: Insulin Sensitivity

Treatments: Behavioral: 12 weeks of lifestyle change

Study type: Interventional

Funder types: Other

Identifiers

NCT01090869

H-KF-2006-6443

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Physical training, unchanged diet

Active Comparator group

Description:

Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet

Treatment:

Behavioral: 12 weeks of lifestyle change

Physical training, increased diet

Active Comparator group

Description:

Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.

Treatment:

Behavioral: 12 weeks of lifestyle change

Diet, unchanged physical activity

Active Comparator group

Description:

Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle

Treatment:

Behavioral: 12 weeks of lifestyle change

Control

No Intervention group

Description:

Unchanged sedentary lifestyle and diet

Treatment:

Behavioral: 12 weeks of lifestyle change