Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

NCT03553381 | Completed

• 1 other identifier: RV_RIC_AT16RCAZZ
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome; Obesity, Metabolically Benign

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Lipoprotein chemical composition

  six months

• Cholesteryl ester transfer protein (CETP)

  six months

Study Arms (2)

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

Interventions

hypocaloric balanced diet OTHER

obese with MS; obese without MS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• roberta cazzola: lead
• Luigi Sacco University Hospital: collaborator
• Istituti Clinici di Perfezionamento di Milano: collaborator

Study Sites (2)

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, 20126, Italy

Location

Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Related 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. doi: 10.1161/01.CIR.0000158483.13093.9D. No abstract available.

  PMID: 15781756 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma and serum, and erythrocytes

MeSH Terms

Conditions

Metabolic Syndrome; Obesity, Metabolically Benign

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberta Cazzola, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 12, 2018
• Study Start: December 30, 2010
• Primary Completion: April 30, 2012
• Study Completion: April 30, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

IT (2)