Obesity
Conditions
Keywords
Obesity, lifestyle, vascular inflammation
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.
Interventions
BEHAVIORALlifestyle 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.
BEHAVIORALControl - general information
General information about healthy food choices and exercise
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 46 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Insulin resistance (HOMA) | 24 months |
Countries
Italy
Outcome results
None listed