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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03553381
Other study ID # RV_RIC_AT16RCAZZ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 30, 2010
Est. completion date April 30, 2018

Study information

Verified date June 2018
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 30, 2018
Est. primary completion date April 30, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Intervention

Other:
hypocaloric balanced diet


Locations

Country Name City State
Italy ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO Milan
Italy Ospedale "L. Sacco" - ASST Fatebenefratelli Sacco Milano

Sponsors (3)

Lead Sponsor Collaborator
roberta cazzola Istituti Clinici di Perfezionamento di Milano, Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 six months
Primary Oxygen Reactive Species (ROS) plasma levels of ROS (mg/dL) six months
Primary Inflammatory markers Plasma levels of cytokines (pg/ml); six months
Secondary 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. six months
Secondary Cholesteryl ester transfer protein (CETP) Plasma levels of CETP (mg/dL) six months
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