Physical Training Per se (TPS)

Physical Activity is Healthy - Effect of Weight Loss or 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.

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity
• Intervention / Treatment: Behavioral: 12 weeks of lifestyle change

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity	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.	week 0 and 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body composition	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.	DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Pernille Nordby, MSc, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 16, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 23, 2010
• Last Update Submitted That Met QC Criteria: March 22, 2010
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: H-KF-2006-6443