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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Rossella Donghia, Biologyst contact

0804994652

rossella.donghia@irccsdebellis.it

Italy1 site, 1 recruiting
  • IRCCS "Saverio de Bellis"

    Castellana Grotte, Bari, 70013

    Rossella Donghia, Biologyst, 0804994652, rossella.donghia@irccsdebellis.it

    Recruiting

Other trials in Italy

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.

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 groups in NCT06372015
Study groupRoleWhat they receive
Control group - Nutritional ApproachPatients who, after a multidisciplinary visit, are found to be ineligible for bariatric surgery.
Receives: Other: Nutritional Approach
Case group - Surgery ApproachPatients 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.

  1. 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

  2. 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

  3. 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.

  1. First posted17 Apr 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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 32690184
  • Sasaki 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 25386164
  • Wolter 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 27272667
  • Ivanova 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 28572872
  • Singh 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

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.

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