Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
NCT ID: NCT00666874
Last Updated: 2008-04-25
Study Results
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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COMPLETED
NA
120 participants
INTERVENTIONAL
1999-02-28
2002-02-28
Brief Summary
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To determine the effect of a program of changes in lifestyle designed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance.
Randomized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy.
One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without diabetes, hypertension, or hyperlipidemia.
The 60 women randomly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity. The control group (n = 60) was given general information about healthy food choices and exercise.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity.
lifestyle changes
Detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity.
2
General information about healthy food choices and exercise
Control - general information
General information about healthy food choices and exercise
Interventions
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lifestyle changes
Detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity.
Control - general information
General information about healthy food choices and exercise
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 20 to 46 years
* sedentary (\<1 h/wk of physical activity)
* with no evidence of participation in diet reduction programs within the last 6 months.
Exclusion Criteria
* hypertension (blood pressure \>140/90 mm Hg)
* cardiovascular disease, psychiatric problems
* history of alcohol abuse (intake of 500 g/wk in the last year)
* current smoking
* any medication use.
20 Years
46 Years
FEMALE
Yes
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Department of Geriatrics and Metabolic Diseases, Second University of Naples
Principal Investigators
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Dario Giugliano, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Geriatrics and metabolic Diseases
Locations
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Department of Geriatrics and Metabolic Diseases
Naples, , Italy
Countries
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References
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Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, Giugliano D. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003 Apr 9;289(14):1799-804. doi: 10.1001/jama.289.14.1799.
Other Identifiers
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DGGM/02/1999
Identifier Type: -
Identifier Source: org_study_id