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Clinical Trials/NCT03553381
NCT03553381
Completed
Not Applicable

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

roberta cazzola2 sites in 1 country80 target enrollmentDecember 30, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
roberta cazzola
Enrollment
80
Locations
2
Primary Endpoint
Lipoprotein and plasma oxidizability
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 30, 2010
End Date
April 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
roberta cazzola
Responsible Party
Sponsor Investigator
Principal Investigator

roberta cazzola

Principal Investigator

University of Milan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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);

Secondary Outcomes

  • Cholesteryl ester transfer protein (CETP)(six months)
  • Lipoprotein chemical composition(six months)

Study Sites (2)

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