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Completed

NCT Number: NCT03553381

Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

hypocaloric balanced diet

Other

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

roberta cazzola

Other

Collaborators

  • Istituti Clinici di Perfezionamento di Milano
  • Luigi Sacco University Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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