Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00666874
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 23, 2008
April 23, 2008
February 1999
December 2001   (final data collection date for primary outcome measure)
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Insulin resistance (HOMA) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women

Obesity is an independent risk factor for cardiovascular disease, which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Behavioral: 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.
    Other Name: lifestyle
  • Behavioral: Control - general information
    General information about healthy food choices and exercise
    Other Name: control
  • Experimental: 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.
    Intervention: Behavioral: lifestyle changes
  • Active Comparator: 2
    General information about healthy food choices and exercise
    Intervention: Behavioral: Control - general information
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2002
December 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • obese premenopausal women,
  • 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:

  • type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL [7.8-11.1 mmol/L] 2 hours after a 75-g oral glucose load)
  • 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.
Female
20 Years to 46 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00666874
DGGM/02/1999
No
Dario Giugliano, MD, Department of Geriatrics and Metabolic Diseases, Second University of Naples
Second University of Naples
Not Provided
Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and metabolic Diseases
Second University of Naples
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP