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

Purpose

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

Condition	Intervention
Obesity Healthy	Behavioral: Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction) 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).

MedlinePlus related topics:

Exercise and Physical Fitness Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

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

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI [ Time Frame: 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue [ Time Frame: 60, 120 240 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EXO: Active Comparator Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction),	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.
DIO: Active Comparator Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet)	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.
DEX: 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).	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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700245

Contacts


Contact: Tore SB Christiansen, Master of health science	004589497737	tore.christiansen@ki.au.dk

Contact: Søren K Paulsen, MD	004589497736	skpaulsen@ki.au.dk

Locations


Denmark
	Department of Medicine and Endocrinology C	Recruiting
	Aarhus, Denmark, 8000
	Contact: Bjørn Richelsen, Professor dr.med 004589497696 brich@dadlnet.dk
	Principal Investigator: Tore Christiansen, M. Health S.

Sponsors and Collaborators

Aarhus University Hospital

More Information

Responsible Party:	Department of Medicine and Endocrinology C ( Tore Christiansen )
Study ID Numbers:	20060053
First Received:	June 17, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00700245
Health Authority:	Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:

Obese

Adults

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

Healthy

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	Aarhus University Hospital
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00700245