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

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ClinicalTrials.gov Identifier: NCT00666874
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : April 25, 2008
Sponsor:
Information provided by:
University of Campania "Luigi Vanvitelli"

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: lifestyle changes Behavioral: Control - general information Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Study Start Date : February 1999
Actual Primary Completion Date : December 2001
Actual Study Completion Date : February 2002

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U.S. FDA Resources

Arm Intervention/treatment
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.
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
Active Comparator: 2
General information about healthy food choices and exercise
Behavioral: Control - general information
General information about healthy food choices and exercise
Other Name: control



Primary Outcome Measures :
  1. Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Insulin resistance (HOMA) [ Time Frame: 24 months ]


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Ages Eligible for Study:   20 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT00666874


Locations
Italy
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and metabolic Diseases

Publications of Results:
Responsible Party: Dario Giugliano, MD, Department of Geriatrics and Metabolic Diseases, Second University of Naples
ClinicalTrials.gov Identifier: NCT00666874     History of Changes
Other Study ID Numbers: DGGM/02/1999
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008

Keywords provided by University of Campania "Luigi Vanvitelli":
Obesity, lifestyle, vascular inflammation

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms