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临床试验/NCT06032312
NCT06032312招募中不适用

Phenotyping Metabolically Healthy Obese Adolescents

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Abdominal fat distribution using abdominal MRI

研究概览

简要总结

Little is known about the associated factors and mechanisms involved in the development of metabolic disturbance in pediatric obesity. The overall objective of the present study is to investigate clinical, anthropometric, socio-demographic and lifestyle predictors of MHO among obese children and adolescents. The Aim of the present study is to investigate the effect of fat distribution, muscle mass, strength and physical activity level on metabolic morbidity in obese adolescents.

详细描述

The global epidemic of childhood obesity and the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities among the youth represents one of the most important public health issues of the modern world. The earlier occurrence and increase in the prevalence of both pediatric obesity and metabolic syndrome (MS) lead to a potential decline in life expectancy such that the youth of today could be the first generation to live shorter lives than their parents.

In the context of the childhood obesity pandemic, a distinct subgroup of obese youth who are less prone to the development of metabolic disturbances, termed "metabolically healthy obese" (MHO), has recently been characterized. Despite their obese state, MHO individuals display a "favorable" metabolic profile, with preserved insulin sensitivity, normal BP and glucose regulation, normal lipid and liver enzyme levels, as well as a normal hormonal, inflammation and immune profile. Although the MHO status might not necessarily translate into lower mortality and can evolve into "metabolically unhealthy obese" (MUO) phenotype during puberty, defining the MHO subpopulation among obese youth is critically important in order to elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors, and their implications on clinical, preventive, and therapeutic decision-making.

Only few studies have evaluated predictors and risk factors for MUO, and they were based on a variety of definitions of MHO and the criteria used for defining it. Moreover, little is known about the mechanisms of the development of metabolic disturbances in pediatric obesity. More data are needed in order to identify the parameters most capable of predicting clinically significant outcomes. In this research, the researchers aim to investigate socio-demographic, clinical, anthropometric, physiological, and lifestyle predictors of MHO.

Aim:

  1. To investigate socio-demographic, clinical, anthropometric, and lifestyle predictors for MHO.
  2. To investigate the interaction between fat mass and distribution, muscle mass and strength and physical activity level on metabolic morbidity in obese adolescents.
  3. To investigate the association between MHO predictors and metabolic disturbances.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 10-18 with obesity
  • Attendance of the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center.

排除标准

  • Children with congenital or acquired heart disease
  • Children with inflammatory conditions
  • Children with neurological conditions that affect body composition

结局指标

主要结局

Abdominal fat distribution using abdominal MRI

时间窗: 3 days

Abdominal fat distribution will be assessed by abdominal MRI. a researchers will calculate the visceral and sub-cutanic fat volume

Dietary pattern in MHO

时间窗: 1 day

Dietary pattern will be assessed by food frequency questioner that will asses consumption of dietary items (from once a day to less than once a month or never)

Body composition (fat and fat free mass) of MHO

时间窗: 1 day

body fat and fat free mass of MHO will be assessed by bioelectrical impedance

physical activity of MHO

时间窗: 3 days

physical activity be assessed by acetometer that will a measure walk distance per day

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eli Sprecher, MD

Prof

Tel-Aviv Sourasky Medical Center

研究点 (1)

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