The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

Healthy Clinical Trial

Official title:

The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00700245
• Other study ID #: 20060053
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2008
• Last updated: June 17, 2008
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: June 2008
• Source: Aarhus University Hospital
• Contact: Tore SB Christiansen, Master of health science
• Phone: 004589497737
• Email: tore.christiansen[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The human adipose and muscle -tissue produce and release a number of bioactive proteins which contributes to the chronic low grade of inflammatory status which is associated with obesity and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular diseases.

Study 1: Our aim is to investigate if exercise has independent and additive effects in combination with diet-induced weight loss on circulating levels of inflammatory markers and mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM.

Study 2: Our aim is to investigate whether gender and weight status plays a role in the metabolic response during two hours of acute exercise

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age 18-45 years,

• obese (30 kg/m2 < BMI < 40 kg/m2) physically inactive (<30 minutes pr. day)

• and weight stabile for at least three months (± 2 kg of current body weight)

Exclusion Criteria:

• cardiovascular disease,

• type 2 diabetes, pregnancy or orthopaedic difficulties causing inability to undertake an exercise program

Study Design

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

Related Conditions & MeSH terms

• Healthy
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)
The exercise intervention for subjects in the EXO consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session. The subjects could choose between different modes of exercise; stationary bicycling, jogging on a treadmill or stair stepping.
• Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet
Subjects in the DIO group were prescribed a liquid VLED(Nupo, Copenhagen) of respectively 600 and 800 kcal pr. day (proteins 41 g, carbohydrates 29 g, fat 5.6 g. pr 100 gram) for eight weeks followed by a weight maintenance diet for four weeks.
• Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).
The exercise intervention for subjects in the DEX group consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session

Locations

Country	Name	City	State
Denmark	Department of Medicine and Endocrinology C	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI		8 weeks and 12 weeks	No
Primary	Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue		60, 120 240 minutes	No