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Clinical and Metabolic, Immunological and Microbiological Characteristics of Obese Patients
Sponsor: Samara State Medical University
Summary
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: 1. 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). 2. 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). 3. To assess the state of the intestinal microbiota in obese children by MALDI-TOF mass spectrometry. 4. 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.
Official title: Clinical and Metabolic, Immunological and Microbiological Characteristics as the Basis of Differentiated Management Tactics for Obese Children
Key Details
Gender
All
Age Range
7 Years - 17 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2023-04-02
Completion Date
2026-04-02
Last Updated
2024-12-11
Healthy Volunteers
Yes
Conditions
Interventions
Determination of the level of interleukins in the blood, stool analysis for the intestinal microbiome, general clinical tests, glucose tolerance test, hormonal profile
comprehensive laboratory and instrumental diagnostics in accordance with federal clinical guidelines on obesity (Peterkova V. A., 2021), including: * general blood test, general urine test, * biochemical blood analysis (total protein, urea, creatinine, total bilirubin, AST, ALT, total cholesterol, high and low density lipoproteins, triglycerides, uric acid, alkaline phosphatase, C-reactive protein), * hormonal profile (T4 free, TSH, cortisol, C-peptide, fasting insulin, stimulated insulin), * glycated hemoglobin, * \- glucose tolerance test, * ultrasound examination of abdominal organs, kidneys (in the presence of arterial hypertension), * blood pressure monitoring. Special laboratory methods: * Blood test to determine the level of HCRP, pro-inflammatory cytokines (leptin, IL-1b, IL-6, IL-8, tumor necrosis factor-α). * analysis of feces for microbiota by MALDI-TOF mass spectrometry, * bioimpedance measurement.
Locations (1)
Samara State Medical University
Samara, Samara Oblast, Russia