Clinical and Metabolic, Immunological and Microbiological Characteristics as the Basis of Differentiated Management Tactics for Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- increased levels of interleukins
研究概览
简要总结
The purpose of the study:
To develop a differentiated management strategy for obese children based on the analysis of the relationship between their clinical, metabolic, immunological and microbiological status
Research objectives:
- To give a clinical and metabolic characteristic of a group of obese children (age, gender, degree of obesity, body mass index SDS, the presence of complications of obesity, clinical signs of metabolic syndrome, laboratory markers: AlT, AsT, cholesterol, high and low density lipoproteins, uric acid, insulin, leptin).
- To study the immunological indicators of inflammation in obese children (the level of highly sensitive CRP, proinflammatory cytokines - IL-1b, IL-6, IL-10, IL-18, TNF-α).
- To assess the state of the intestinal microbiota in obese children by MALDI-TOF mass spectrometry.
- To analyze the relationship of clinical-metabolic, immunological and microbiological status in obese children and identify markers associated with metabolic syndrome and the formation of complications.
Materials and methods:
At stage 1, it is planned to conduct a cohort study in a group of school-age children with obesity (n=120) with the study of their clinical, metabolic, immunological and microbiological status. The control group will consist of healthy children of the appropriate age who are not overweight (n= 20).
Stage 2 of the study consists in prospective observation of children of the examined group who do not have complications and clinical manifestations of metabolic syndrome for 6 months against the background of standard therapeutic measures (diet, lifestyle correction, physical activity) and repeated clinical and laboratory examination.
详细描述
The aim of the study:
To develop differentiated management tactics for obese children based on the analysis of the relationship between their clinical, metabolic, immunological and microbiological status.
Research objectives:
- To give a clinical and metabolic characteristic of a group of obese children (age, gender, degree of obesity, body mass index SDS, the presence of complications of obesity, clinical signs of metabolic syndrome, laboratory markers: AlT, AsT, cholesterol, high and low density lipoproteins, uric acid, insulin, leptin).
- To study the immunological indicators of inflammation in obese children (the level of highly sensitive CRP, proinflammatory cytokines - IL-1b, IL-6, IL-10, IL-18, TNF-α).
- To assess the state of the intestinal microbiota in obese children by MALDI-TOF mass spectrometry.
- To analyze the relationship of clinical-metabolic, immunological and microbiological status in obese children and identify markers associated with metabolic syndrome and the formation of complications.
- To evaluate the effectiveness of the standard approach to the management of obese children, depending on the characteristics of their clinical, metabolic, immunological and microbiological status, to propose clinical and laboratory predictors of its inefficiency and differentiated management tactics.
The novelty of the study:
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The presence of a diagnosis of "obesity of egzogenic-constitutional genesis" (according to the criteria of WHO anthropometric standards with the calculation of the standard sigma deviation - SDS using the WHO-AnthroPlus program).
- •The age of children from 7 to 16 years inclusive.
- •Absence of clinically significant concomitant somatic diseases that have a potential impact on the growth, weight and physical development of the child, as well as syndromic or monogenic forms of obesity (Prader-Willi syndrome, Alstrom, etc.)
- •The availability of voluntary informed consent of the legal representative or a child (over 14 years old) for the processing, storage and analysis of personal data obtained during the study.
排除标准
- •The presence in the anamnesis of any acute infectious diseases, exacerbations of chronic infectious diseases, as well as concomitant diseases affecting the physical development of the child.
- •The presence of syndromic and monogenic forms of obesity.
- •Taking medications that affect the child's appetite (glucocorticosteroids, neuroleptics, antidepressants, etc.).
- •Lack of signed informed consent for inclusion in the study.
结局指标
主要结局
increased levels of interleukins
时间窗: 02.04.2024 - 15.12.2024
in patients with metabolic unhealthy obesity, there is an increase in inflammatory markers in the blood serum
次要结局
未报告次要终点