Metabolic SyndromeNCT03553381
Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome
An observational study of Metabolic Syndrome and Obesity, Metabolically Benign, run by roberta cazzola at 2 sites in Italy.
Trial summary
Obesity is associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. Metabolic syndrome exacerbate low grade inflammation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Metabolic Syndrome, Obesity, Metabolically Benign
- What is being tested?
- hypocaloric balanced diet
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Dec 2010to 30 Apr 2018
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects were males and females overweight or moderately obese with or without metabolic syndrome on a calorie-controlled diet. Those that lost at least 5% of the initial weight were analyzed.
- Inclusion Criteria.
1.a Group "Obese with MS":
- BMI between 25 e 35 Kg/m2
- presence at least three of the following:1) waist circumference >102 cm for males or > 88 cm for females; 2) triglycerides: ≥ 150 mg/dL;3) HDL-cholesterol < 40 mg/dL in males or < 50 mg/dL in females; 4) hypertension (systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg or antihypertensive intake); 5) glycemia: ≥ 110 mg/dL
- Alcohol consumption < 25 g/die
- No smoking or smoking less that 5 cigarettes/die
- No use of antioxidant based supplements
- Absence of hormonal treatments
- Informed consent signature 1.b Group "Obese without MS":
- BMI between 25 e 35 Kg/m2
- Alcohol consumption < 25 g/die
- No smoking or smoking less that 5 cigarettes/die
- No use of antioxidant based supplements
- Absence of hormonal treatments
- Informed consent signature
- Exclusion Criteria
- Presence of major disease
- Receiving hypoglycemic treatment
- Receiving treatments that alter lipoprotein metabolism
- Receiving hormonal treatments
- Use of antioxidant supplement
- Alcohol consumption > 25 g/die
- Smoking > 5 cigarettes/die.
- For women:pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, 20126
Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco
Milan, 20157
About this study
Official title: Oxidative Stress, Inflammation, and Lipoprotein Chemical Composition in Obesity and Metabolic Syndrome: Effects of Diet-induced Weigh Loss
Obesity is associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. Metabolic syndrome exacerbate low grade inflammation. The intentional weight loss of at least 5% of the initial weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the metabolic syndrome, thus diminishing the cardiovascular risk.
Read the detailed description
Metabolic syndrome is a clustering of risk factors for the development of cardiovascular disease and type 2 diabetes mellitus. Patients with metabolic syndrome have an increased general low grade inflammation and, consequently, of oxidative stress that affects properties and functions of lipoproteins (Dandona et al 2005). Intentional weight loss can improve or prevent many of the metabolic syndrome-related risk factors and these benefits are often found after weight loss of at least 5% of initial weigh.
Aim: i) to investigate the structure and functionality of plasma lipoproteins, oxidative stress and the inflammatory condition in subjects with BMI between 25kg/mq and 35 kg/mq and with or without metabolic syndrome; and ii) to test the effects of weight loss of at least 5% of initial weigh promoted by an hypo-caloric balanced diet on these parameters.
Methods: Eighty overweight and moderately obese subjects (BMI: 25 - 35 kg/m2) with or without metabolic syndrome were recruited for the study. Fasting blood samples were taken and analyzed for routine laboratory analysis, lipoprotein isolation and analysis, and oxidative stress and inflammation markers measurements. The subjects received an hypo-caloric balanced diet. Fasting blood samples were taken from subjects who had lost at least 5% of their initial weight at the end of the intervention period and analyzed for same markers determined at baseline.
- Conditions
- Metabolic Syndrome, Obesity, Metabolically Benign
- Being tested
- hypocaloric balanced diet
- Medical subject headings
- Metabolic Syndrome, Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypocaloric balanced dietOther
| Study group | Role | What they receive |
|---|---|---|
| obese without MS | BMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet Receives: Other: hypocaloric balanced diet | |
| obese with MS | BMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet Receives: Other: hypocaloric balanced diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoprotein and plasma oxidizability
kinetics of 2,2'-diazobis-(2-amidinopropane)-dihydrochloride (AAPH)- induced peroxidation of plasma, LDL or HDL labeled with fluorescent probes. The length of the lag phase (lag-time) and the velocity of the reaction in the propagation phase (slope) of peroxidation kinetic curves are used as indices of sample oxidizability
Measured: six months
Oxygen Reactive Species (ROS)
plasma levels of ROS (mg/dL)
Measured: six months
Inflammatory markers
Plasma levels of cytokines (pg/ml);
Measured: six months
Secondary outcomes (2)
Lipoprotein chemical composition
Levels of proteins (mg/dL), triacylglycerol (mg/dL), free and esterified cholesterol (mg/dL) and phospholipids (mg/dL) of very low density lipoprotein (VLDL), LDL and HDL.
Measured: six months
Cholesteryl ester transfer protein (CETP)
Plasma levels of CETP (mg/dL)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start30 Dec 2010
- Primary completion30 Apr 2012
- Study completion30 Apr 2018
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 Metabolic SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- roberta cazzola
- Sponsor type
- University, hospital or other
- Collaborators
- Luigi Sacco University Hospital, Istituti Clinici di Perfezionamento di Milano
- Responsible party
- Sponsor-investigator, roberta cazzola, University of Milan
- Investigators
- Roberta Cazzola, PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553381
- Sponsor's protocol ID
- RV_RIC_AT16RCAZZ
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dandona P, Aljada A, Chaudhuri A, Mohanty P, Garg R. Metabolic syndrome: a comprehensive perspective based on interactions between obesity, diabetes, and inflammation. Circulation. 2005 Mar 22;111(11):1448-54. doi: 10.1161/01.CIR.0000158483.13093.9D. No abstract available.
PubMed 15781756
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress, Inflammation, and Lipoprotein Chemical Composition in Obesity and Metabolic Syndrome: Effects of Diet-induced Weigh Loss
- ClinicalTrials.gov ID
- NCT03553381
- Acronym / sponsor ID
- RV_RIC_AT16RCAZZ
- Conditions
- Metabolic Syndrome, Obesity, Metabolically Benign
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- roberta cazzolaUniversity, hospital or other
- Collaborators
- Luigi Sacco University Hospital, Istituti Clinici di Perfezionamento di Milano
- Study start
- 30 Dec 2010 (actual)
- Primary completion
- 30 Apr 2012 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 12 Jun 2018 (actual)
- 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 associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. Metabolic syndrome exacerbate low grade inflammation. The intentional weight loss of at least 5% of the initial weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the metabolic syndrome, thus diminishing the cardiovascular risk.
Detailed description
Metabolic syndrome is a clustering of risk factors for the development of cardiovascular disease and type 2 diabetes mellitus. Patients with metabolic syndrome have an increased general low grade inflammation and, consequently, of oxidative stress that affects properties and functions of lipoproteins (Dandona et al 2005). Intentional weight loss can improve or prevent many of the metabolic syndrome-related risk factors and these benefits are often found after weight loss of at least 5% of initial weigh.
Aim: i) to investigate the structure and functionality of plasma lipoproteins, oxidative stress and the inflammatory condition in subjects with BMI between 25kg/mq and 35 kg/mq and with or without metabolic syndrome; and ii) to test the effects of weight loss of at least 5% of initial weigh promoted by an hypo-caloric balanced diet on these parameters.
Methods: Eighty overweight and moderately obese subjects (BMI: 25 - 35 kg/m2) with or without metabolic syndrome were recruited for the study. Fasting blood samples were taken and analyzed for routine laboratory analysis, lipoprotein isolation and analysis, and oxidative stress and inflammation markers measurements. The subjects received an hypo-caloric balanced diet. Fasting blood samples were taken from subjects who had lost at least 5% of their initial weight at the end of the intervention period and analyzed for same markers determined at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese without MS | – | Other: hypocaloric balanced dietBMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet |
| obese with MS | – | Other: hypocaloric balanced dietBMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects were males and females overweight or moderately obese with or without metabolic syndrome on a calorie-controlled diet. Those that lost at least 5% of the initial weight were analyzed.
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 |
|---|---|---|
| hypocaloric balanced diet | Other | obese with MS, obese without MS |
Primary outcome
Lipoprotein and plasma oxidizability
Time frame: six months
kinetics of 2,2'-diazobis-(2-amidinopropane)-dihydrochloride (AAPH)- induced peroxidation of plasma, LDL or HDL labeled with fluorescent probes. The length of the lag phase (lag-time) and the velocity of the reaction in the propagation phase (slope) of peroxidation kinetic curves are used as indices of sample oxidizability
Oxygen Reactive Species (ROS)
Time frame: six months
plasma levels of ROS (mg/dL)
Inflammatory markers
Time frame: six months
Plasma levels of cytokines (pg/ml);
2 secondary outcomes
Lipoprotein chemical composition
Time frame: six months
Cholesteryl ester transfer protein (CETP)
Time frame: six 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 12 Jun 2018.
- Background: PubMed 15781756Dandona P, Aljada A, Chaudhuri A, Mohanty P, Garg R. Metabolic syndrome: a comprehensive perspective based on interactions between obesity, diabetes, and inflammation. Circulation. 2005 Mar 22;111(11):1448-54. doi: 10.1161/01.CIR.0000158483.13093.9D. No abstract available.
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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.
Roberta Cazzola, PhD principal investigator
University of Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Obesity, Metabolically Benign, run by roberta cazzola at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Lipoprotein and plasma oxidizability (time frame: six months). The study lists 3 primary outcomes in all. 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 NCT03553381, 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 12 Jun 2018.