NCT00666874

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: Female
• Age: 20 Years – 46 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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.
BEHAVIORAL	Control - general information	General information about healthy food choices and exercise

Timeline

• Start date: 1999-02-01
• Primary completion: 2001-12-01
• Completion: 2002-02-01
• First posted: 2008-04-25
• Last updated: 2008-04-25

Locations

1 site across 1 country: Italy