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Physical Training Per se (TPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090869
First Posted: March 23, 2010
Last Update Posted: March 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Copenhagen
  Purpose
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.

Condition Intervention
Insulin Sensitivity Behavioral: 12 weeks of lifestyle change

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physical training, unchanged diet
Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet
Behavioral: 12 weeks of lifestyle change
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.
Active Comparator: Physical training, increased diet
Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.
Behavioral: 12 weeks of lifestyle change
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.
Active Comparator: Diet, unchanged physical activity
Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle
Behavioral: 12 weeks of lifestyle change
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.
No Intervention: Control
Unchanged sedentary lifestyle and diet
Behavioral: 12 weeks of lifestyle change
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.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090869


Locations
Denmark
University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Pernille Nordby, MSc University of Copenhagen
  More Information

Responsible Party: Ph.D., D.Ms. Bente M. Stallknecht, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01090869     History of Changes
Other Study ID Numbers: H-KF-2006-6443
First Submitted: March 16, 2010
First Posted: March 23, 2010
Last Update Posted: March 23, 2010
Last Verified: October 2007

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases