Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

Completed

• Conditions: Metabolic Syndrome; Obesity, Metabolically Benign
• Interventions: Other: hypocaloric balanced diet

• Registration Number: NCT03553381
• Lead Sponsor: roberta cazzola

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.

Study Timeline

• Study Start: 2010-12-30
• Primary Completion: 2012-04-30
• Study Completion: 2018-04-30
• Study First Submitted: 2018-05-22
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-11
• Last Update Submitted: 2018-06-11
• Study First Posted: 2018-06-12
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese without MS	hypocaloric balanced diet	BMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet
obese with MS	hypocaloric balanced diet	BMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet

Primary Outcome Measures

Name	Time	Method
Lipoprotein and plasma oxidizability	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)	six months	plasma levels of ROS (mg/dL)
Inflammatory markers	six months	Plasma levels of cytokines (pg/ml);

Secondary Outcome Measures

Name	Time	Method
Cholesteryl ester transfer protein (CETP)	six months	Plasma levels of CETP (mg/dL)
Lipoprotein chemical composition	six months	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.

Trial Locations

Locations (2)

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO; 🇮🇹 Milan, Italy

Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco; 🇮🇹 Milano, Italy