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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Obesity

Treatments: Behavioral: lifestyle changes; Behavioral: Control - general information

Study type: Interventional

Funder types: Other

Identifiers

NCT00666874

DGGM/02/1999

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 20 to 46 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

1

Experimental group

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.

Treatment:

Behavioral: lifestyle changes

2

Active Comparator group

Description:

General information about healthy food choices and exercise

Treatment:

Behavioral: Control - general information