Obesity Clinical Trial
Official title:
Metabolically Healthy Obesity in Pediatric Population- Prevalence, Predictors and the Effect of Heart Rate Variability
The global epidemic of childhood obesity, with the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities in youth, represents one of the most important public health issues of the modern world. Nevertheless, a distinct subgroup of youth with obesity less prone to the development of metabolic disturbances, called "metabolically healthy obese" (MHO), has come into focus. Defining the MHO subpopulation within the youth with obesity is of high importance in order to elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors, and for its clinical, preventive, and therapeutic decision-making implications. Little is known about the mechanisms of development of metabolic disturbance in pediatric obesity. Cardiac autonomic function, which can be measured non-invasively with heart rate variability (HRV), has been suggested as a potential mechanism underlying the development of metabolic syndrome and cardiovascular disease. The aims of the present study were to investigate clinical, anthropometric, and socio-demographic and lifestyle predictors of MHO in this group and to asses correlation between HRV and the metabolic syndrome progression or improvement , in order to reveal if HRV can serve as a predictor to metabolic disturbance in pediatric obesity population Materials and Methods The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital. All children and adolescents that that will be admitted to our clinic between January 2021 to December 2022 will include in the study. sociodemographic parameters will be collected from the medical files.Blood will be drawn for complete metabolic assesment. MUO children will be defined according to the recent international definition. Resting HRV will be measured by Pulse Oximeter (BM2000A/Shanghai Berry Electronic Tech Co., Ltd.). The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 30, 2022 |
Est. primary completion date | January 15, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: All children 10-18 with obesity, males and females, who attend the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center, will be included Exclusion Criteria: Children with conditions that may affect HRV (e.g. congenital or acquired heart disease, other inflammatory conditions) will be excluded. withdrawal criteria: children and parents that will refuse to participate in the telephone interview will withdrawl from the study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tel-Aviv Sourasky Medical Center |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prevalnce of metabolic disorder in obese pediatric population | measurment of glucose , insulin and lipid profile in all th chorot | 2 years | |
Secondary | heart rate variability | heart rate variability will be measured in all the cohort and compared between metabolicaly healthy to non healthy obese | 2 years |
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