NCT05920785

Brief 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. 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. 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. 3.To assess the state of the intestinal microbiota in obese children by MALDI-TOF mass spectrometry.
  4. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

2.7 years

First QC Date

June 17, 2023

Last Update Submit

December 10, 2024

Conditions

Obesity

Keywords

childhood obesity

Outcome Measures

Primary Outcomes (1)

  • increased levels of interleukins

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

    02.04.2024 - 15.12.2024

Study Arms (3)

Metabolically healthy obesity

Patients diagnosed with "exogenous constitutional obesity", but without complications of this disease

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

Metabolically unhealthy obesity

Patients diagnosed with "Exogenous constitutional obesity" with the presence of complications of this disease: arterial hypertension, dyslipidemia, impaired carbohydrate metabolism, type 2 diabetes hyperuricemia

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

Control group

Healthy children with normal body weight

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

Interventions

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

Control groupMetabolically healthy obesityMetabolically unhealthy obesity

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

a group of obese school-age children (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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samara State Medical University

Samara, Samara Oblast, 443079, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum to determine the level of interleukins

MeSH Terms

Conditions

ObesityPediatric Obesity

Interventions

Occult BloodGlucose Tolerance Test

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Chemical AnalysisClinical Chemistry TestsDiagnostic Techniques, Endocrine

Study Officials

  • Natalia B Migacheva, PhD

    Samara State Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2023

First Posted

June 27, 2023

Study Start

April 2, 2023

Primary Completion

December 15, 2025

Study Completion

April 2, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)