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OpenTrials
Completed

NCT Number: NCT01090869

Physical Training Per se

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.

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Key information

Conditions

Insulin Sensitivity Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12 weeks of lifestyle change

Behavioral

Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.

Primary outcomes

  1. 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

  1. Changes in body composition

    Time frame: DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13

    Before, during and after the 12-week interventions changes in: Body mass, Lean body mass, Fat mass, Abdominal fat mass, and Viceral and subcutaneous fat were assesed by DEXA and MRI scans.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?

Acronym: TPS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 23, 2010
Registry last updated
Mar 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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