Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920785
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-06
First Post:
2023-06-17
Brief Title:
Clinical and Metabolic Immunological and Microbiological Characteristics of Obese Patients
Sponsor:
Samara State Medical University
Organization:
Samara State Medical University
Study Overview
Official Title:
Clinical and Metabolic Immunological and Microbiological Characteristics as the Basis of Differentiated Management Tactics for Obese Children
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 n120 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
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 n120 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
Detailed Description:
The aim of the study
To develop differentiated management tactics 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
5 To evaluate the effectiveness of the standard approach to the management of obese children depending on the characteristics of their clinical metabolic immunological and microbiological status to propose clinical and laboratory predictors of its inefficiency and differentiated management tactics
The novelty of the study
For the first time a comprehensive assessment of the clinical metabolic immunological and microbiological status of obese children in the Russian Federation will be carried out For the first time the relationship between the level of inflammatory markers metabolic profile data and the state of the intestinal microbiota depending on the clinical characteristics of obese patients will be studied For the first time the effectiveness of the standard approach to the treatment of obesity will be analyzed depending on the characteristics of the clinical metabolic immunological and microbiological status in obese children
Practical significance
Based on the results of the study metabolic immunological and microbiological markers associated with the development of complications of childhood obesity and predictors of the ineffectiveness of the standard approach to the management of obese children will be developed as well as tactics for their differentiated management will be proposed
Materials and methods
At stage 1 it is planned to conduct a cohort study in a group of school-age children with obesity n120 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
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 Availability of voluntary informed consent of the legal representative or the child over 14 years old for the processing storage and analysis of personal data the 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 childs appetite glucocorticosteroids neuroleptics antidepressants etc
4 Lack of signed informed consent for inclusion in the study
Description of the study
The study includes 2 stages The first stage includes a general clinical examination of the patient which includes
collection of complaints and anamnesis life history family history endocrinological history
features and nature of family and child nutrition
assessment of motor activity
assessment of the emotional state of the parents and the child
general examination data assessment of the condition of the skin the type of distribution of subcutaneous fat the state of the musculoskeletal system assessment of the stage of puberty etc
anthropometric parameters measurement of height and weight calculation of SDS body mass index determination of waisthip ratio index
evaluation of the obtained anthropometric data using percentile tables and the WHO-AnthroPlus computer program
In addition comprehensive laboratory and instrumental diagnostics will be carried out in accordance with the 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-tolerant test
ultrasound examination of abdominal organs kidneys in the presence of hypertension
blood pressure monitoring
Special laboratory methods
a 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 The results of the examination will be processed to identify the relationship of the clinical metabolic immunological and microbiological status of obese children with their clinical characteristics degree of obesity age sex of SDS body mass index complications of obesity
Statistical processing of the received data will be carried out using the Statistica software package The systematization of the data will be given in the form of a standard deviation M SD The statistical significance of the differences will be made using the calculated Mann-Whitney U-test The relationship between the studied features and parameters will be evaluated using Pearson chi-square The differences will be considered statistically significant at p005
Depending on the results of the examination patients will be given recommendations on lifestyle changes and the nature of nutrition aimed at reducing body weight according to federal clinical guidelines
Before the second stage of the study children who do not require pathogenetic therapy to correct complications of obesity ie who do not have impaired carbohydrate metabolism severe insulin resistance or type 2 diabetes mellitus will be admitted The second stage of the study will include two visits - 3 and 6 months after discharge from the hospital during which the following
general examination assessment of the condition of the skin the type of distribution of subcutaneous fat assessment of the stage of puberty etc
assessment of the emotional state of the child
measurement of anthropometric parameters measurement of height and weight calculation of BMI measurement of waist and hip circumference
evaluation of the obtained anthropometric data using percentile tables and the WHO-AnthroPlus computer program
analysis of the blood pressure monitoring diary
assessment of patient compliance
correction of recommendations for lifestyle changes the nature of nutrition if necessary correction of drug therapy
All patients regardless of the achieved result in weight loss will also undergo a repeated laboratory examination the volume of which corresponds to the volume of studies at stage 1
All received data will also be subjected to statistical processing
Research hypothesis
Identification of a positive correlation of individual indicators of clinical and metabolic visceral fat level percentage of fat according to bioimpedance cholesterol low and high density lipoproteins AlT AsT uric acid immunological HCRP leptin IL-1b IL-6 IL-10 IL-18 TNF-α and microbiological status or their associations with weight SDS body mass index the presence of complications of obesity as well as the ineffectiveness of the standard approach to the management of children during the observation process
To develop differentiated management tactics 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
5 To evaluate the effectiveness of the standard approach to the management of obese children depending on the characteristics of their clinical metabolic immunological and microbiological status to propose clinical and laboratory predictors of its inefficiency and differentiated management tactics
The novelty of the study
For the first time a comprehensive assessment of the clinical metabolic immunological and microbiological status of obese children in the Russian Federation will be carried out For the first time the relationship between the level of inflammatory markers metabolic profile data and the state of the intestinal microbiota depending on the clinical characteristics of obese patients will be studied For the first time the effectiveness of the standard approach to the treatment of obesity will be analyzed depending on the characteristics of the clinical metabolic immunological and microbiological status in obese children
Practical significance
Based on the results of the study metabolic immunological and microbiological markers associated with the development of complications of childhood obesity and predictors of the ineffectiveness of the standard approach to the management of obese children will be developed as well as tactics for their differentiated management will be proposed
Materials and methods
At stage 1 it is planned to conduct a cohort study in a group of school-age children with obesity n120 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
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 Availability of voluntary informed consent of the legal representative or the child over 14 years old for the processing storage and analysis of personal data the 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 childs appetite glucocorticosteroids neuroleptics antidepressants etc
4 Lack of signed informed consent for inclusion in the study
Description of the study
The study includes 2 stages The first stage includes a general clinical examination of the patient which includes
collection of complaints and anamnesis life history family history endocrinological history
features and nature of family and child nutrition
assessment of motor activity
assessment of the emotional state of the parents and the child
general examination data assessment of the condition of the skin the type of distribution of subcutaneous fat the state of the musculoskeletal system assessment of the stage of puberty etc
anthropometric parameters measurement of height and weight calculation of SDS body mass index determination of waisthip ratio index
evaluation of the obtained anthropometric data using percentile tables and the WHO-AnthroPlus computer program
In addition comprehensive laboratory and instrumental diagnostics will be carried out in accordance with the 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-tolerant test
ultrasound examination of abdominal organs kidneys in the presence of hypertension
blood pressure monitoring
Special laboratory methods
a 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 The results of the examination will be processed to identify the relationship of the clinical metabolic immunological and microbiological status of obese children with their clinical characteristics degree of obesity age sex of SDS body mass index complications of obesity
Statistical processing of the received data will be carried out using the Statistica software package The systematization of the data will be given in the form of a standard deviation M SD The statistical significance of the differences will be made using the calculated Mann-Whitney U-test The relationship between the studied features and parameters will be evaluated using Pearson chi-square The differences will be considered statistically significant at p005
Depending on the results of the examination patients will be given recommendations on lifestyle changes and the nature of nutrition aimed at reducing body weight according to federal clinical guidelines
Before the second stage of the study children who do not require pathogenetic therapy to correct complications of obesity ie who do not have impaired carbohydrate metabolism severe insulin resistance or type 2 diabetes mellitus will be admitted The second stage of the study will include two visits - 3 and 6 months after discharge from the hospital during which the following
general examination assessment of the condition of the skin the type of distribution of subcutaneous fat assessment of the stage of puberty etc
assessment of the emotional state of the child
measurement of anthropometric parameters measurement of height and weight calculation of BMI measurement of waist and hip circumference
evaluation of the obtained anthropometric data using percentile tables and the WHO-AnthroPlus computer program
analysis of the blood pressure monitoring diary
assessment of patient compliance
correction of recommendations for lifestyle changes the nature of nutrition if necessary correction of drug therapy
All patients regardless of the achieved result in weight loss will also undergo a repeated laboratory examination the volume of which corresponds to the volume of studies at stage 1
All received data will also be subjected to statistical processing
Research hypothesis
Identification of a positive correlation of individual indicators of clinical and metabolic visceral fat level percentage of fat according to bioimpedance cholesterol low and high density lipoproteins AlT AsT uric acid immunological HCRP leptin IL-1b IL-6 IL-10 IL-18 TNF-α and microbiological status or their associations with weight SDS body mass index the presence of complications of obesity as well as the ineffectiveness of the standard approach to the management of children during the observation process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None