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
|Condition or disease||Intervention/treatment|
|Metabolic Syndrome Obesity, Metabolically Benign||Other: hypocaloric balanced diet|
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|
|Actual Enrollment :||80 participants|
|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|
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
- 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);
- 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)
Biospecimen Retention: Samples Without DNA
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
|Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco|
|Milano, Italy, 20157|
|ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO|
|Milan, Italy, 20126|
|Principal Investigator:||Roberta Cazzola, PhD||University of Milan|