NCT05920785Completed
Clinical and Metabolic, Immunological and Microbiological Characteristics of Obese Patients
Clinical and Metabolic, Immunological and Microbiological Characteristics as the Basis of Differentiated Management Tactics for Obese Children
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 17 Jun 2023
- Start date
- 2 Apr 2023
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Samara State Medical University
- Diseases
- Obesity
- NCT number
- NCT05920785
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 2 Apr 2023 to the primary completion date, 15 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Taking medications that affect the child's appetite (glucocorticosteroids, neuroleptics, antidepressants, etc.).
Other
- The presence of syndromic and monogenic forms of obesity.
- Lack of signed informed consent for inclusion in the study.
Who the study is looking for
- 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.
Age in the registry: 7 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samara State Medical University Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.