ObesityNCT00666874
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
A study testing lifestyle changes in people with Obesity, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Feb 1999to Feb 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- lifestyle changes, Control - general information
- Keywords
- Obesity, lifestyle, vascular inflammation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle changesBehavioural
Also called lifestyle
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.
Control - general informationBehavioural
Also called control
General information about healthy food choices and exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: lifestyle changes |
| 2 | Active comparator | General information about healthy food choices and exercise Receives: Behavioral: Control - general information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)
Measured: 24 months
Secondary outcomes (1)
Insulin resistance (HOMA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startFeb 1999
- Primary completionDec 2001
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Investigators
- Dario Giugliano, MD,PhD, Principal investigator, Department of Geriatrics and metabolic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666874
- Sponsor's protocol ID
- DGGM/02/1999
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12684358
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
- ClinicalTrials.gov ID
- NCT00666874
- Acronym / sponsor ID
- DGGM/02/1999
- Conditions
- Obesity
- Keywords
- Obesity, lifestyle, vascular inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Feb 1999
- Primary completion
- Dec 2001 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: lifestyle changesDetailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity. |
| 2 | Active comparator | Behavioral: Control - general informationGeneral information about healthy food choices and exercise |
Who may qualify
- Ages
- 20 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle changesAlso: lifestyleDetailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity. | Behavioural | 1 |
| Control - general informationAlso: controlGeneral information about healthy food choices and exercise | Behavioural | 2 |
Primary outcome
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)
Time frame: 24 months
1 secondary outcome
Insulin resistance (HOMA)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2008.
- Results publication: PubMed 12684358Esposito 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Giugliano, MD,PhD principal investigator
Department of Geriatrics and metabolic Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle changes in people with Obesity, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2008.