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Clinical and Metabolic, Immunological and Microbiological Characteristics of Obese Patients

NCT05920785 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Samara State Medical University

    lead OTHER

Principal Investigators

  • Natalia B Migacheva, PhD · Samara State Medical University

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-02
Primary Completion
2025-12-15
Completion
2026-04-02

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05920785 on ClinicalTrials.gov