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Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

Oxidative Stress, Inflammation, and Lipoprotein Chemical Composition in Obesity and Metabolic Syndrome: Effects of Diet-induced Weigh Loss

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03553381
Enrollment
80
Registered
2018-06-12
Start date
2010-12-30
Completion date
2018-04-30
Last updated
2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity, Metabolically Benign

Brief 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. 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.

Interventions

Sponsors

Luigi Sacco University Hospital
CollaboratorOTHER
Istituti Clinici di Perfezionamento di Milano
CollaboratorOTHER
roberta cazzola
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1\. 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 2\.

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygen Reactive Species (ROS)six monthsplasma levels of ROS (mg/dL)
Lipoprotein and plasma oxidizabilitysix monthskinetics 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
Inflammatory markerssix monthsPlasma levels of cytokines (pg/ml);

Secondary

MeasureTime frameDescription
Lipoprotein chemical compositionsix monthsLevels 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.
Cholesteryl ester transfer protein (CETP)six monthsPlasma levels of CETP (mg/dL)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026