Cardiovascular disease in adolescents with obesity Circulatory System Cardiovascular disease, atherosclerosis
Conditions
Interventions
This study was a randomized placebo-controlled trial with a double-blinded (to the participant and the investigator who gave the treatment) design.
Randomization and allocation to tri
Sponsors
Mexican Social Security Institute
Universidad de Guanajuato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 15 to 19 years 2. =1 of the following cardiovascular risk factors: 2.1. Obesity, defined as a body mass index (BMI) for age more than 2 standard deviations above the median established in the World Health Organization (WHO) Child Growth Standards 2.2. Altered lipid profile, defined as: total cholesterol >70 mg/dl; LDL cholesterol >110 mg/dl; HDL cholesterol 100 mg/dl; elevated triglycerides >90 mg/dl; or insulin resistance with Homeostatic Model Assessment of Insulin Resistance (HOMA IR) >3 3. Non-smokers
Exclusion criteria
Exclusion criteria: 1. Do not agree to adhere to at least 80% of diet and fiber 2. Diagnosis of a metabolic and/or infectious disease during the study 3. Do not wish to continue in the study or unable to be located for follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Anthropometric and biochemical markers measured using the following at baseline and 7 weeks: 1.1. The height and weight of the child measured using a SECA stadiometer (to the nearest 0.1 cm) and a SECA scales (to the nearest 0.1 kg), and body mass index (BMI) was calculated as kilogram per square meter (kg/m2) 1.2. Waist circumference (WC) measured using Lufkin ® metallic tape (to the nearest 1mm) 1.3. LDL and HDL subclasses measured using a venous blood sample obtained after 12 h of fasting processed using the Lipoprint system (Quantimetrix) 1.4. IL-6 measured using an ELISA assay of a venous blood sample was obtained after 12 h of fasting | — |
Secondary
| Measure | Time frame |
|---|---|
| Somatometric variables measured using the following at baseline and 7 weeks: 1.1. Blood pressure measured using an Omron® digital baumanometer 1.2. Glucose measured using a venous blood sample obtained after 12 h of fasting processed using enzymatic methods in an autoanalyzer (Spinreact-Spinlab, Model 6002390-412-02) 1.3. Homeostatic Model Assessment of Insulin Resistance (HOMA IR) measured using an ELISA assay of a venous blood sample was obtained after 12 h of fasting 1.4. Lipid profile measured using a venous blood sample obtained after 12 h of fasting processed using enzymatic methods in an autoanalyzer (Spinreact-Spinlab, Model 6002390-412-02) 1.5. The atherogenic index (AI) calculated as total cholesterol/HDL-C using measurements from a venous blood sample obtained after 12 h of fasting processed using enzymatic methods in an autoanalyzer (Spinreact-Spinlab, Model 6002390-412-02) and the Lipoprint system (Quantimetrix) | — |
Countries
Mexico
Contacts
Public ContactPatricia;Patricia González;Sosa
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Outcome results
None listed