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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance (HOMA) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 46 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666874

Locations
Italy
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
Second University of Naples
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
Study First Received: April 23, 2008
Last Updated: April 23, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Second University of Naples:
Obesity, lifestyle, vascular inflammation

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013