Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553381
• Other study ID #: RV_RIC_AT16RCAZZ
• Status: Completed
• Start date: December 30, 2010
• Est. completion date: April 30, 2018

Study information

• Verified date: June 2018
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Obesity, Metabolically Benign
• Syndrome

Intervention

Other:
• hypocaloric balanced diet

Locations

Country	Name	City	State
Italy	ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO	Milan
Italy	Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco	Milano

Sponsors (3)

Lead Sponsor	Collaborator
roberta cazzola	Istituti Clinici di Perfezionamento di Milano, Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Oxygen Reactive Species (ROS)	plasma levels of ROS (mg/dL)	six months
Primary	Inflammatory markers	Plasma levels of cytokines (pg/ml);	six months
Secondary	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
Secondary	Cholesteryl ester transfer protein (CETP)	Plasma levels of CETP (mg/dL)	six months