Physical Training Per se

Not Applicable

Completed

• Conditions: Insulin Sensitivity
• Interventions: Behavioral: 12 weeks of lifestyle change

• Registration Number: NCT01090869
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study Start: 2007-03
• Status Verified: 2007-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-22
• Last Update Submitted: 2010-03-22
• Study First Posted: 2010-03-23
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical training, unchanged diet	12 weeks of lifestyle change	Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet
Physical training, increased diet	12 weeks of lifestyle change	Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.
Diet, unchanged physical activity	12 weeks of lifestyle change	Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle
Control	12 weeks of lifestyle change	Unchanged sedentary lifestyle and diet

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	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

Name	Time	Method
Changes in body composition	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.

Trial Locations

Locations (1)

University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences; 🇩🇰 Copenhagen, Denmark