Physical Training Per se (TPS)
Primary Purpose
Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
12 weeks of lifestyle change
Sponsored by

About this trial
This is an interventional prevention trial for Insulin Sensitivity
Eligibility 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
Sites / Locations
- University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Physical training, unchanged diet
Physical training, increased diet
Diet, unchanged physical activity
Control
Arm Description
Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet
Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.
Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle
Unchanged sedentary lifestyle and diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01090869
First Posted
March 16, 2010
Last Updated
March 22, 2010
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01090869
Brief Title
Physical Training Per se
Acronym
TPS
Official Title
Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical training, unchanged diet
Arm Type
Active Comparator
Arm Description
Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet
Arm Title
Physical training, increased diet
Arm Type
Active Comparator
Arm Description
Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.
Arm Title
Diet, unchanged physical activity
Arm Type
Active Comparator
Arm Description
Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle
Arm Title
Control
Arm Type
No Intervention
Arm Description
Unchanged sedentary lifestyle and diet
Intervention Type
Behavioral
Intervention Name(s)
12 weeks of lifestyle change
Intervention Description
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 Outcome Measure Information:
Title
Change in insulin sensitivity
Description
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.
Time Frame
week 0 and 13
Secondary Outcome Measure Information:
Title
Changes in body composition
Description
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.
Time Frame
DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille Nordby, MSc
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
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Physical Training Per se
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