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

NCT ID: NCT00700245

Last Updated: 2008-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Obesity Healthy

Keywords

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Obese Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EXO

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

DIO

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

DEX

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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).

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Medicine and Endocrinology C

Locations

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Department of Medicine and Endocrinology C

Aarhus, Aarhus, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Tore SB Christiansen, Master of health science

Role: CONTACT

Phone: 004589497737

Email: [email protected]

Søren K Paulsen, MD

Role: CONTACT

Phone: 004589497736

Email: [email protected]

Facility Contacts

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Bjørn Richelsen, Professor dr.med

Role: primary

Other Identifiers

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20060053

Identifier Type: -

Identifier Source: org_study_id