Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

NCT ID: NCT03553381

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-30
• Study Completion Date: 2018-04-30

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.

Conditions

Metabolic Syndrome; Obesity, Metabolically Benign

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

obese without MS

BMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet

hypocaloric balanced diet

Intervention Type: OTHER

obese with MS

BMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet

hypocaloric balanced diet

Intervention Type: OTHER

Interventions

hypocaloric balanced diet

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luigi Sacco University Hospital

OTHER

Sponsor Role: collaborator

Istituti Clinici di Perfezionamento di Milano

OTHER

Sponsor Role: collaborator

roberta cazzola

OTHER

Sponsor Role: lead

Responsible Party

roberta cazzola

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roberta Cazzola, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, , Italy

Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco

Milan, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 15781756 (View on PubMed)

Other Identifiers

RV_RIC_AT16RCAZZ

Identifier Type: -

Identifier Source: org_study_id