ObesityNCT06372015
Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery
An observational study of Obesity and Liver Disease Parenchymal, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis. The association of these pathologies compromises the patient's survival and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Liver Disease Parenchymal
- What is being tested?
- Nutritional Approach and Surgery Approach
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients with hepato-biliary pathology, who refer to the nutrition clinic
Who may be able to join
- Obese patients (BMI >30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan
- Adult patients (>18 years).
Who cannot join
- Patients who are not obese or not affected by hepato-biliary pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS "Saverio de Bellis"
Castellana Grotte, Bari, 70013
Rossella Donghia, Biologyst, 0804994652, rossella.donghia@irccsdebellis.it
About this study
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
Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.
The association of these pathologies compromises the patient's 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.
Read more
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.
Read the detailed description
Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.
The association of these pathologies compromises the patient's 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 (P.D.T.A) is regulated by DDG n. 528 of 10/27/2022, 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 (P.D.T.A)" of the body - DDG no. 528 of 10/27/2022) 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.
- Conditions
- Obesity, Liver Disease Parenchymal
- Being tested
- Nutritional Approach, Surgery Approach
- Keywords
- Obesity, Liver Diseases, Bariatric Surgery
- Medical subject headings
- Obesity, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional ApproachOther
Nutritional Approach
Surgery ApproachOther
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group - Nutritional Approach | Patients who, after a multidisciplinary visit, are found to be ineligible for bariatric surgery. Receives: Other: Nutritional Approach | |
| Case group - Surgery Approach | Patients who, after a multidisciplinary visit, are referred for bariatric surgery. Receives: Other: Surgery Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of lipidomic parameters
Variation of lipidomic parameters measured by extraction of fatty acids from red blood cells and run in gas chromatography
Measured: at Baseline and at 1 year
The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis
Evaluate how bariatric surgery affects routine blood chemistry parameters. The following will be taken into consideration: Blood sugar, Glycated hemoglobin, triglycerides, total cholesterol, HDL and LDL, transaminases, γGT, creatinine, uric acid
Measured: at Baseline and at 1 year
Variation in the microRNA profile
Evaluation of microRNA profile change by real-time PCR
Measured: at Baseline and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Collaborators
- Notarnicola Maria, Cozzolongo Raffaele, Shahini Endrit, De Pergola Giovanni, Lippolis Giuseppe
- Responsible party
- Principal investigator, Dr. Rossella Donghia, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Rossella Donghia, Biologyst, Principal investigator, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372015
- Sponsor's protocol ID
- RC2023-24
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bischoff SC, Schweinlin A. Obesity therapy. Clin Nutr ESPEN. 2020 Aug;38:9-18. doi: 10.1016/j.clnesp.2020.04.013. Epub 2020 May 11.
PubMed 32690184Sasaki A, Nitta H, Otsuka K, Umemura A, Baba S, Obuchi T, Wakabayashi G. Bariatric surgery and non-alcoholic Fatty liver disease: current and potential future treatments. Front Endocrinol (Lausanne). 2014 Oct 27;5:164. doi: 10.3389/fendo.2014.00164. eCollection 2014.
PubMed 25386164Wolter S, Dupree A, Coelius C, El Gammal A, Kluwe J, Sauer N, Mann O. Influence of Liver Disease on Perioperative Outcome After Bariatric Surgery in a Northern German Cohort. Obes Surg. 2017 Jan;27(1):90-95. doi: 10.1007/s11695-016-2253-6.
PubMed 27272667Ivanova EA, Myasoedova VA, Melnichenko AA, Grechko AV, Orekhov AN. Small Dense Low-Density Lipoprotein as Biomarker for Atherosclerotic Diseases. Oxid Med Cell Longev. 2017;2017:1273042. doi: 10.1155/2017/1273042. Epub 2017 May 7.
PubMed 28572872Singh S, Muir AJ, Dieterich DT, Falck-Ytter YT. American Gastroenterological Association Institute Technical Review on the Role of Elastography in Chronic Liver Diseases. Gastroenterology. 2017 May;152(6):1544-1577. doi: 10.1053/j.gastro.2017.03.016.
PubMed 28442120
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06372015
- Acronym / sponsor ID
- RC2023-24
- Conditions
- Obesity, Liver Disease Parenchymal
- Keywords
- Obesity, Liver Diseases, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Collaborators
- Notarnicola Maria, Cozzolongo Raffaele, Shahini Endrit, De Pergola Giovanni, Lippolis Giuseppe
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.
The association of these pathologies compromises the patient's 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 (BMI>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.
The association of these pathologies compromises the patient's 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 (P.D.T.A) is regulated by DDG n. 528 of 10/27/2022, 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 (P.D.T.A)" of the body - DDG no. 528 of 10/27/2022) 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - Nutritional Approach | – | Other: Nutritional ApproachPatients who, after a multidisciplinary visit, are found to be ineligible for bariatric surgery. |
| Case group - Surgery Approach | – | Other: Surgery ApproachPatients who, after a multidisciplinary visit, are referred for bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with hepato-biliary pathology, who refer to the nutrition clinic
Key inclusion criteria (2 listed)
- Obese patients (BMI >30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan
- Adult patients (>18 years).
Key exclusion criteria (1 listed)
- Patients who are not obese or not affected by hepato-biliary pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional ApproachNutritional Approach | Other | Control group - Nutritional Approach |
| Surgery ApproachBariatric surgery | Other | Case group - Surgery Approach |
Primary outcome
Variation of lipidomic parameters
Time frame: at Baseline and at 1 year
Variation of lipidomic parameters measured by extraction of fatty acids from red blood cells and run in gas chromatography
The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis
Time frame: at Baseline and at 1 year
Evaluate how bariatric surgery affects routine blood chemistry parameters. The following will be taken into consideration: Blood sugar, Glycated hemoglobin, triglycerides, total cholesterol, HDL and LDL, transaminases, γGT, creatinine, uric acid
Variation in the microRNA profile
Time frame: at Baseline and at 1 year
Evaluation of microRNA profile change by real-time PCR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 32690184Bischoff SC, Schweinlin A. Obesity therapy. Clin Nutr ESPEN. 2020 Aug;38:9-18. doi: 10.1016/j.clnesp.2020.04.013. Epub 2020 May 11.
- Background: PubMed 25386164Sasaki A, Nitta H, Otsuka K, Umemura A, Baba S, Obuchi T, Wakabayashi G. Bariatric surgery and non-alcoholic Fatty liver disease: current and potential future treatments. Front Endocrinol (Lausanne). 2014 Oct 27;5:164. doi: 10.3389/fendo.2014.00164. eCollection 2014.
- Background: PubMed 27272667Wolter S, Dupree A, Coelius C, El Gammal A, Kluwe J, Sauer N, Mann O. Influence of Liver Disease on Perioperative Outcome After Bariatric Surgery in a Northern German Cohort. Obes Surg. 2017 Jan;27(1):90-95. doi: 10.1007/s11695-016-2253-6.
- Background: PubMed 28572872Ivanova EA, Myasoedova VA, Melnichenko AA, Grechko AV, Orekhov AN. Small Dense Low-Density Lipoprotein as Biomarker for Atherosclerotic Diseases. Oxid Med Cell Longev. 2017;2017:1273042. doi: 10.1155/2017/1273042. Epub 2017 May 7.
- Background: PubMed 28442120Singh S, Muir AJ, Dieterich DT, Falck-Ytter YT. American Gastroenterological Association Institute Technical Review on the Role of Elastography in Chronic Liver Diseases. Gastroenterology. 2017 May;152(6):1544-1577. doi: 10.1053/j.gastro.2017.03.016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rossella Donghia, Biologyst principal investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Liver Disease Parenchymal, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rossella Donghia, Biologyst (0804994652, rossella.donghia@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of lipidomic parameters (time frame: at Baseline and at 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372015, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.