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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: lifestyle changes
* Behavioral: Control - general information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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: lifestyle changes<br>* 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.<br>* Other names: lifestyle;|
| Active Comparator: 2<br>General information about healthy food choices and exercise | Behavioral: Control - general information<br>* General information about healthy food choices and exercise<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance (HOMA) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, lifestyle, vascular inflammation