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OpenTrials
Completed

NCT Number: NCT00666874

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Geriatrics and Metabolic Diseases

Naples, 80138, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lifestyle changes

Behavioral

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.

Other names: lifestyle

Control - general information

Behavioral

General information about healthy food choices and exercise

Other names: control

Primary outcomes

  1. Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)

    Time frame: 24 months

Secondary outcomes

  1. Insulin resistance (HOMA)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Important dates

Study start
1999
Primary completion
2001
Study completion
2002
First posted
Apr 25, 2008
Registry last updated
Apr 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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