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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Obesity, Metabolically Benign
• Intervention / Treatment: Other: hypocaloric balanced diet

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20126
    • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
  • Milano, Italy, 20157
    • Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obese without MS; BMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet	Other: hypocaloric balanced diet
obese with MS; BMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet	Other: hypocaloric balanced diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six months
Oxygen Reactive Species (ROS)	plasma levels of ROS (mg/dL)	six months
Inflammatory markers	Plasma levels of cytokines (pg/ml);	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months
Cholesteryl ester transfer protein (CETP)	Plasma levels of CETP (mg/dL)	six months

Collaborators and Investigators

• Sponsor: roberta cazzola
• Collaborators: Istituti Clinici di Perfezionamento di Milano; Luigi Sacco University Hospital
• Investigators: Principal Investigator: Roberta Cazzola, PhD, University of Milan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2010
• Primary Completion (ACTUAL): April 30, 2012
• Study Completion (ACTUAL): April 30, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Inflammation; Metabolic Syndrome; Obesity, Metabolically Benign
• Other Study ID Numbers: RV_RIC_AT16RCAZZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No