An observational study in Metabolic Syndrome and Obesity, Metabolically Benign, sponsored by roberta cazzola. Completed at 2 sites in Italy. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-06-12.
Sponsored by roberta cazzola · Observational
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 80 is below the median of 135 across 1,283 observational studies indexed under Obesity.
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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.
1.a Group "Obese with MS":
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1.b Group "Obese without MS":
BMI 25- 35 Kg/mq without metabolic syndrome (MS) submitted to hypocaloric balanced diet
Other: hypocaloric balanced diet
BMI 25- 35 Kg/mq with metabolic syndrome submitted to hypocaloric balanced diet
Other: hypocaloric balanced diet
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
Time frame: six months
Oxygen Reactive Species (ROS)
plasma levels of ROS (mg/dL)
Time frame: six months
Inflammatory markers
Plasma levels of cytokines (pg/ml);
Time frame: six months
Lipoprotein chemical composition
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.
Time frame: six months
Cholesteryl ester transfer protein (CETP)
Plasma levels of CETP (mg/dL)
Time frame: six months
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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