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Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

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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

Tracking Information
First Submitted Date May 22, 2018
First Posted Date June 12, 2018
Last Update Posted Date June 12, 2018
Actual Study Start Date December 30, 2010
Actual Primary Completion Date April 30, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2018)
  • 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
  • Oxygen Reactive Species (ROS) [ Time Frame: six months ]
    plasma levels of ROS (mg/dL)
  • Inflammatory markers [ Time Frame: six months ]
    Plasma levels of cytokines (pg/ml);
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 11, 2018)
  • 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.
  • Cholesteryl ester transfer protein (CETP) [ Time Frame: six months ]
    Plasma levels of CETP (mg/dL)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome
Official Title Oxidative Stress, Inflammation, and Lipoprotein Chemical Composition in Obesity and Metabolic Syndrome: Effects of Diet-induced Weigh Loss
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood plasma and serum, and erythrocytes
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.

Condition
  • Metabolic Syndrome
  • Obesity, Metabolically Benign
Intervention Other: hypocaloric balanced diet
Study Groups/Cohorts
  • obese without MS
    BMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet
    Intervention: Other: hypocaloric balanced diet
  • obese with MS
    BMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet
    Intervention: Other: hypocaloric balanced diet
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2018)
80
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2018
Actual Primary Completion Date April 30, 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03553381
Other Study ID Numbers RV_RIC_AT16RCAZZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party roberta cazzola, University of Milan
Study Sponsor roberta cazzola
Collaborators
  • Luigi Sacco University Hospital
  • Istituti Clinici di Perfezionamento di Milano
Investigators
Principal Investigator: Roberta Cazzola, PhD University of Milan
PRS Account University of Milan
Verification Date June 2018