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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Obese patients (BMI >30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan

Adult patients (>18 years).

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Nutritional Approach

    Other intervention

    Nutritional Approach

  • Surgery Approach

    Other intervention

    Bariatric surgery

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control group - Nutritional Approach1 intervention
Group B: Case group - Surgery Approach1 intervention

Trial outcomes

Primary outcomes

1

Variation of lipidomic parameters

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

Time frame
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

Time frame
at Baseline and at 1 year
3

Variation in the microRNA profile

Evaluation of microRNA profile change by real-time PCR

Time frame
at Baseline and at 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Lead sponsor

Notarnicola Maria

Collaborator

Cozzolongo Raffaele

Collaborator

Shahini Endrit

Collaborator

De Pergola Giovanni

Collaborator

Lippolis Giuseppe

Collaborator