Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06372015

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Liver Disease Parenchymal

Full registry criteria

Inclusion Criteria: * Obese patients (BMI \>30kg/m2) suffering from hepato-biliary pathology diagnosed by Fibroscan * Adult patients (\>18 years). Exclusion Criteria: * Patients who are not obese or not affected by hepato-biliary pathology

Treatments and study arms

Nutritional Approach

Other

Nutritional Approach

Surgery Approach

Other

Bariatric surgery

Primary outcomes

Variation of lipidomic parametersat 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 fibrosisat 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 profileat Baseline and at 1 year

Evaluation of microRNA profile change by real-time PCR

Study locations

1 locations were listed when this page was built. The first 40 are shown.

IRCCS "Saverio de Bellis"🇮🇹 Castellana Grotte, Bari, Italy
Rossella Donghia, BiologystContact