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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
lifestyle changes
Control - general information
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, lifestyle, vascular inflammation

Eligibility Criteria

20 Years - 46 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Geriatrics and Metabolic Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

General information about healthy food choices and exercise

Outcomes

Primary Outcome Measures

Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)

Secondary Outcome Measures

Insulin resistance (HOMA)

Full Information

First Posted
April 23, 2008
Last Updated
April 23, 2008
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT00666874
Brief Title
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Official Title
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
February 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, lifestyle, vascular inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
General information about healthy food choices and exercise
Intervention Type
Behavioral
Intervention Name(s)
lifestyle changes
Other Intervention Name(s)
lifestyle
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Control - general information
Other Intervention Name(s)
control
Intervention Description
General information about healthy food choices and exercise
Primary Outcome Measure Information:
Title
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Insulin resistance (HOMA)
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Giugliano, MD,PhD
Organizational Affiliation
Department of Geriatrics and metabolic Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Geriatrics and Metabolic Diseases
City
Naples
ZIP/Postal Code
80138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12684358
Citation
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.
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Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women

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