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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666874
First Posted: April 25, 2008
Last Update Posted: April 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campania "Luigi Vanvitelli"
  Purpose

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 Intervention
Obesity Behavioral: lifestyle changes Behavioral: Control - general information

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Campania "Luigi Vanvitelli":

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

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

Enrollment: 120
Study Start Date: February 1999
Study Completion Date: February 2002
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.
  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): 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
  More Information

Publications:
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 Submitted: April 23, 2008
First Posted: April 25, 2008
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


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