Clinical trial

Clinical and Metabolic, Immunological and Microbiological Characteristics of Obese Patients

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05920785

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 17 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

Inclusion Criteria: 1. 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). 2. The age of children from 7 to 16 years inclusive. 3. 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.) 4. 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. Exclusion Criteria: 1. 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. 2. The presence of syndromic and monogenic forms of obesity. 3. Taking medications that affect the child's appetite (glucocorticosteroids, neuroleptics, antidepressants, etc.). 4. Lack of signed informed consent for inclusion in the study.

Treatments and study arms

Determination of the level of interleukins in the blood, stool analysis for the intestinal microbiome, general clinical tests, glucose tolerance test, hormonal profile

Diagnostic Test

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.

Primary outcomes

increased levels of interleukins02.04.2024 - 15.12.2024

in patients with metabolic unhealthy obesity, there is an increase in inflammatory markers in the blood serum

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Samara State Medical University🌐 Samara, Samara Oblast, Russia

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