Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372015
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-05
Brief Title:
Changes in the Lipidomic Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery
Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Organization:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Study Overview
Official Title:
Changes in the Lipidomic Immunological and Circulating microRNA Profile in Patients With Hepatobiliary Pathology Suffering From Morbid Obesity Undergoing a Dietary Program or Bariatric Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Obesity is a chronic disease characterized phenotypically by an increase in body weight BMI30 kgm2 and by a series of associated pathologies such as hypertension diabetes hepatic steatosis
The association of these pathologies compromises the patients survival and quality of life The multifactorial origin of obesity makes its etiopathology difficult to manage It is often possible to follow only one therapeutic strategy especially after the so-called standard treatments such as dietary intervention and physical activity have not brought benefit to the patient In these cases an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery
Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity and treating the diseases associated with it
Among the different types of bariatric surgery the techniques most used in common clinical practice are intragastric balloons gastric by pass RYGB and sleeve gastrectomy
The choice of the surgeon assisted by the multidisciplinary team is binding in the choice of the type of operation to which the patient will be subjected
The association of these pathologies compromises the patients survival and quality of life The multifactorial origin of obesity makes its etiopathology difficult to manage It is often possible to follow only one therapeutic strategy especially after the so-called standard treatments such as dietary intervention and physical activity have not brought benefit to the patient In these cases an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery
Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity and treating the diseases associated with it
Among the different types of bariatric surgery the techniques most used in common clinical practice are intragastric balloons gastric by pass RYGB and sleeve gastrectomy
The choice of the surgeon assisted by the multidisciplinary team is binding in the choice of the type of operation to which the patient will be subjected
Detailed Description:
Obesity is a chronic disease characterized phenotypically by an increase in body weight BMI30 kgm2 and by a series of associated pathologies such as hypertension diabetes hepatic steatosis
The association of these pathologies compromises the patients survival and quality of life The multifactorial origin of obesity makes its etiopathology difficult to manage It is often possible to follow only one therapeutic strategy especially after the so-called standard treatments such as dietary intervention and physical activity have not brought benefit to the patient In these cases an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery
Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity and treating the diseases associated with it
Among the different types of bariatric surgery the techniques most used in common clinical practice are intragastric balloons gastric by pass RYGB and sleeve gastrectomy
In our institution the diagnostic therapeutic care path for the integrated treatment of obese patients PDTA is regulated by DDG n 528 of 10272022 which indicates the path that the patient must follow if he decides to evaluate a Bariatric Surgery procedure
In order to proceed with this type of approach the patient must be followed by a multidisciplinary team the doctor the dietician the psychologist and the kinesiologist so that the patient can significantly improve his state of health
The choice of the surgeon assisted by the multidisciplinary team is binding in the choice of the type of operation to which the patient will be subjected
Every patient with obesity associated with hepato-biliary pathologies hepatic steatosis gallstones or inflammation of the bile ducts diagnosed by ultrasound of the complete abdomen and Fibroscan will be directed towards the procedure most suitable for his health status In the event that the surgeon does not deem it appropriate and safe for the patient proceed with any bariatric surgery the guidelines and normal clinical practice Diagnostic therapeutic care path for the integrated treatment of the obese patient PDTA of the body - DDG no 528 of 10272022 provide that the patient is directed to a nutritional approach through the administration of a diet always with a multidisciplinary contribution in which the figure of the psychologist plays great importance since these patients are often affected by Eating Behavior Disorders DCA and have altered eating behavior hyperphagia gorging sweet eating grazing snacking
In obese patients candidates for bariatric surgery weight loss is only the phenotypic aspect of a metabolic change affecting cellular physiology
Considering this aspect lipidomics analysis would be a useful approach to evaluate the composition of fatty acids and membranes of an organism as well as understanding the alteration of the cellular pathways involved The measurement of small dense lipoproteins sdLDL will be added to the lipidomic profile which are more common in some dyslipidemias and can be oxidized more easily than larger LDLs which oxidized in the cell wall stimulate the production of cytokines and growth factors resulting in the recruitment of monocytes
From a biological point of view obesity as well as the alteration of metabolism involves not only a variation of the lipidomic pattern but also of the inflammatory pattern with dysregulation of circulating cytokines and the modification of the expression of circulating microRNAs which emerges from the literature are associated with insulin resistance as well as alterations in glucose homeostasis and regulators of endocrine function
Adipose tissue has numerous endocrine functions capable of stimulating an inflammatory response by regulatory T lymphocytes and macrophages The activation of these immune cells determines the secretion of pro-inflammatory cytokines such as TNF IFN-γ IL-1β IL-6 IL-8
The presence of high levels of pro-inflammatory cytokines in circulation has been observed in obese patients which can determine the establishment of an inflammatory microenvironment in different body areas Studies in the literature have shown that weight loss achieved with dietary or surgical therapeutic methods can produce different results in the synthesis of inflammatory mediators Therefore future studies are necessary to determine the predictive role of inflammatory mediators in patients undergoing bariatric surgery
The association of these pathologies compromises the patients survival and quality of life The multifactorial origin of obesity makes its etiopathology difficult to manage It is often possible to follow only one therapeutic strategy especially after the so-called standard treatments such as dietary intervention and physical activity have not brought benefit to the patient In these cases an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery
Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity and treating the diseases associated with it
Among the different types of bariatric surgery the techniques most used in common clinical practice are intragastric balloons gastric by pass RYGB and sleeve gastrectomy
In our institution the diagnostic therapeutic care path for the integrated treatment of obese patients PDTA is regulated by DDG n 528 of 10272022 which indicates the path that the patient must follow if he decides to evaluate a Bariatric Surgery procedure
In order to proceed with this type of approach the patient must be followed by a multidisciplinary team the doctor the dietician the psychologist and the kinesiologist so that the patient can significantly improve his state of health
The choice of the surgeon assisted by the multidisciplinary team is binding in the choice of the type of operation to which the patient will be subjected
Every patient with obesity associated with hepato-biliary pathologies hepatic steatosis gallstones or inflammation of the bile ducts diagnosed by ultrasound of the complete abdomen and Fibroscan will be directed towards the procedure most suitable for his health status In the event that the surgeon does not deem it appropriate and safe for the patient proceed with any bariatric surgery the guidelines and normal clinical practice Diagnostic therapeutic care path for the integrated treatment of the obese patient PDTA of the body - DDG no 528 of 10272022 provide that the patient is directed to a nutritional approach through the administration of a diet always with a multidisciplinary contribution in which the figure of the psychologist plays great importance since these patients are often affected by Eating Behavior Disorders DCA and have altered eating behavior hyperphagia gorging sweet eating grazing snacking
In obese patients candidates for bariatric surgery weight loss is only the phenotypic aspect of a metabolic change affecting cellular physiology
Considering this aspect lipidomics analysis would be a useful approach to evaluate the composition of fatty acids and membranes of an organism as well as understanding the alteration of the cellular pathways involved The measurement of small dense lipoproteins sdLDL will be added to the lipidomic profile which are more common in some dyslipidemias and can be oxidized more easily than larger LDLs which oxidized in the cell wall stimulate the production of cytokines and growth factors resulting in the recruitment of monocytes
From a biological point of view obesity as well as the alteration of metabolism involves not only a variation of the lipidomic pattern but also of the inflammatory pattern with dysregulation of circulating cytokines and the modification of the expression of circulating microRNAs which emerges from the literature are associated with insulin resistance as well as alterations in glucose homeostasis and regulators of endocrine function
Adipose tissue has numerous endocrine functions capable of stimulating an inflammatory response by regulatory T lymphocytes and macrophages The activation of these immune cells determines the secretion of pro-inflammatory cytokines such as TNF IFN-γ IL-1β IL-6 IL-8
The presence of high levels of pro-inflammatory cytokines in circulation has been observed in obese patients which can determine the establishment of an inflammatory microenvironment in different body areas Studies in the literature have shown that weight loss achieved with dietary or surgical therapeutic methods can produce different results in the synthesis of inflammatory mediators Therefore future studies are necessary to determine the predictive role of inflammatory mediators in patients undergoing bariatric surgery
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