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Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553381
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Luigi Sacco University Hospital
Istituti Clinici di Perfezionamento di Milano
Information provided by (Responsible Party):
roberta cazzola, University of Milan

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.

Condition or disease Intervention/treatment
Metabolic Syndrome Obesity, Metabolically Benign 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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Stress, Inflammation, and Lipoprotein Chemical Composition in Obesity and Metabolic Syndrome: Effects of Diet-induced Weigh Loss
Actual Study Start Date : December 30, 2010
Actual Primary Completion Date : April 30, 2012
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. Oxygen Reactive Species (ROS) [ Time Frame: six months ]
    plasma levels of ROS (mg/dL)

  3. Inflammatory markers [ Time Frame: six months ]
    Plasma levels of cytokines (pg/ml);


Secondary Outcome Measures :
  1. Lipoprotein chemical composition [ Time Frame: six months ]
    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.

  2. Cholesteryl ester transfer protein (CETP) [ Time Frame: six months ]
    Plasma levels of CETP (mg/dL)


Biospecimen Retention:   Samples Without DNA
blood plasma and serum, and erythrocytes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553381


Locations
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Italy
Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco
Milano, Italy, 20157
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Italy, 20126
Sponsors and Collaborators
roberta cazzola
Luigi Sacco University Hospital
Istituti Clinici di Perfezionamento di Milano
Investigators
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Principal Investigator: Roberta Cazzola, PhD University of Milan

Publications:
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Responsible Party: roberta cazzola, Principal Investigator, University of Milan
ClinicalTrials.gov Identifier: NCT03553381    
Other Study ID Numbers: RV_RIC_AT16RCAZZ
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Obesity, Metabolically Benign
Syndrome
Inflammation
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases