Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery

NCT06372015 | Recruiting

• 1 other identifier: RC2023-24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Liver Disease Parenchymal

Keywords

Obesity; Liver Diseases; Bariatric Surgery

Outcome Measures

Primary Outcomes (3)

• Variation of lipidomic parameters

  Variation of lipidomic parameters measured by extraction of fatty acids from red blood cells and run in gas chromatography

  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

  at Baseline and at 1 year

• Variation in the microRNA profile

  Evaluation of microRNA profile change by real-time PCR

  at Baseline and at 1 year

Study Arms (2)

Control group - Nutritional Approach

Patients who, after a multidisciplinary visit, are found to be ineligible for bariatric surgery.

Other: Nutritional Approach

Case group - Surgery Approach

Patients who, after a multidisciplinary visit, are referred for bariatric surgery.

Other: Surgery Approach

Interventions

Nutritional Approach OTHER

Nutritional Approach

Control group - Nutritional Approach

Surgery Approach OTHER

Bariatric surgery

Case group - Surgery Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients with hepato-biliary pathology, who refer to the nutrition clinic

You may qualify if:

• Obese patients (BMI \>30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan
• Adult patients (\>18 years).

You may not qualify if:

• Patients who are not obese or not affected by hepato-biliary pathology

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Notarnicola Maria: collaborator
• Cozzolongo Raffaele: collaborator
• Shahini Endrit: collaborator
• De Pergola Giovanni: collaborator
• Lippolis Giuseppe: collaborator

Study Sites (1)

IRCCS "Saverio de Bellis"

Castellana Grotte, Bari, 70013, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 32690184 BACKGROUND

• 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.

  PMID: 25386164 BACKGROUND

• 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.

  PMID: 27272667 BACKGROUND

• 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.

  PMID: 28572872 BACKGROUND

• 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.

  PMID: 28442120 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Obesity; Liver Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Officials

• Rossella Donghia, Biologyst

  Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rossella Donghia, Biologyst

CONTACT

0804994652; rossella.donghia@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biologyst

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)