NCT00666874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 1999

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
Last Updated

April 25, 2008

Status Verified

April 1, 2008

Enrollment Period

2.8 years

First QC Date

April 23, 2008

Last Update Submit

April 23, 2008

Conditions

Obesity

Keywords

Obesity, lifestyle, vascular inflammation

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (1)

  • Insulin resistance (HOMA)

    24 months

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

General information about healthy food choices and exercise

Behavioral: Control - general information

Interventions

lifestyle changesBEHAVIORAL

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.

Also known as: lifestyle
1
Control - general informationBEHAVIORAL

General information about healthy food choices and exercise

Also known as: control
2

Eligibility Criteria

Age20 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatrics and Metabolic Diseases

Naples, 80138, Italy

Location

Related Publications (1)

  • Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, Giugliano D. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003 Apr 9;289(14):1799-804. doi: 10.1001/jama.289.14.1799.

    PMID: 12684358RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dario Giugliano, MD,PhD

    Department of Geriatrics and metabolic Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

February 1, 1999

Primary Completion

December 1, 2001

Study Completion

February 1, 2002

Last Updated

April 25, 2008

Record last verified: 2008-04

Locations

IT(1)