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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: lifestyle changes; Behavioral: Control - general information

• Registration Number: NCT00666874
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-02
• Primary Completion: 2001-12
• Study Completion: 2002-02
• Status Verified: 2008-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Last Update Submitted: 2008-04-23
• Study First Posted: 2008-04-25
• Last Update Posted: 2008-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	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.
2	Control - general information	General information about healthy food choices and exercise

Primary Outcome Measures

Name	Time	Method
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)	24 months

Secondary Outcome Measures

Name	Time	Method
Insulin resistance (HOMA)	24 months

Trial Locations

Locations (1)

Department of Geriatrics and Metabolic Diseases; 🇮🇹 Naples, Italy