Skip to main content
Clinical Trials/NCT01090869
NCT01090869CompletedNot Applicable

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

University of Copenhagen1 site in 1 country60 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Change in insulin sensitivity

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Physical training, unchanged diet

Active Comparator

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

Intervention: 12 weeks of lifestyle change (Behavioral)

Physical training, increased diet

Active Comparator

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

Intervention: 12 weeks of lifestyle change (Behavioral)

Diet, unchanged physical activity

Active Comparator

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

Intervention: 12 weeks of lifestyle change (Behavioral)

Control

No Intervention

Unchanged sedentary lifestyle and diet

Intervention: 12 weeks of lifestyle change (Behavioral)

Outcomes

Primary Outcomes

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

  • Changes in body composition(DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13)

Investigators

Sponsor Class
Other

Study Sites (1)

Loading locations...

Similar Trials