Physical Training Per se

NCT01090869 | Completed

• 1 other identifier: H-KF-2006-6443
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in body composition

  DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13

Study Arms (4)

Physical training, unchanged diet

ACTIVE COMPARATOR

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

Behavioral: 12 weeks of lifestyle change

Physical training, increased diet

ACTIVE COMPARATOR

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

Behavioral: 12 weeks of lifestyle change

Diet, unchanged physical activity

ACTIVE COMPARATOR

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

Behavioral: 12 weeks of lifestyle change

Control

NO INTERVENTION

Unchanged sedentary lifestyle and diet

Behavioral: 12 weeks of lifestyle change

Interventions

12 weeks of lifestyle change BEHAVIORAL

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.

Control; Diet, unchanged physical activity; Physical training, increased diet; Physical training, unchanged diet

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Resistance training
• Inability to meet intervention criteria

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pernille Nordby, MSc

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 23, 2010
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 23, 2010

Record last verified: 2007-10

Locations

DK (1)