Physical Training Per se

Insulin Sensitivity Clinical Trial

— TPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090869
• Other study ID #: H-KF-2006-6443
• Status: Completed
• Phase: N/A
• First received: March 16, 2010
• Last updated: March 22, 2010
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: October 2007
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Sensitivity

Intervention

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.

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No