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

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ClinicalTrials.gov Identifier: NCT00700245
Recruitment Status : Unknown
Verified June 2008 by Aarhus University Hospital.
Recruitment status was:  Recruiting
First Posted : June 18, 2008
Last Update Posted : June 18, 2008
Sponsor:
Information provided by:

Study Description
Brief 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


Condition or disease Intervention/treatment
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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects
Study Start Date : September 2006
Estimated Primary Completion Date : June 2008
Estimated Study Completion Date : March 2009


Arms and Interventions

Arm Intervention/treatment
Active Comparator: EXO
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.
Active Comparator: DIO
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.
Active Comparator: 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).
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue [ Time Frame: 60, 120 240 minutes ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Tore Christiansen, Department of Medicine and Endocrinology C
ClinicalTrials.gov Identifier: NCT00700245     History of Changes
Other Study ID Numbers: 20060053
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: June 18, 2008
Last Verified: June 2008

Keywords provided by Aarhus University Hospital:
Obese
Adults

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases