Clinical and Metabolic, Immunological and Microbiological Characteristics of Obese Patients

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Minor Trial completed
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 37 words
  2. Notable Primary completion date: Dec 15, 2024 to Dec 15, 2025
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 50
    • Study completion date: Apr 2, 2025 to Apr 2, 2026
    v3
  3. Notable Primary completion date: Dec 15, 2023 to Dec 15, 2024
    • Study completion date: Apr 2, 2024 to Apr 2, 2025
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05920785
Lead Sponsor Samara State Medical University
Conditions
(from sponsor)
Obesity
Related terms Obesity, Pediatric Obesity
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov