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

Aarhus University Hospital

Status: Unknown

Conditions: Healthy; Obesity

Treatments: Behavioral: Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet; Behavioral: Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).; Behavioral: Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)

Study type: Interventional

Funder types: Other

Identifiers

NCT00700245

20060053

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

EXO

Active Comparator group

Description:

Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction),

Treatment:

Behavioral: Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)

DIO

Active Comparator group

Description:

Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet)

Treatment:

Behavioral: Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet

DEX

Active Comparator group

Description:

Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Treatment:

Behavioral: Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).