Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

NCT ID: NCT04984785

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-09-07

Brief Summary

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The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.

Detailed Description

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The study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. The evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. For the study samples are stored identified by a code to be analyzed anonymously. Study interruption criteria are: development of allergic reactions, ketonemia\> 1.5 mmol/L, acute gout

Conditions

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Bariatric Surgery Candidate Lipid Metabolism Disorders Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* subjects with pathological obesity suitable for bariatric surgery
* Body Mass Index (BMI) range 35-59

Exclusion Criteria

* established diagnoses of a major disease (e.g., diabetes or kidney disease)
* pregnancy or breastfeeding,
* food allergies,
* use of drugs that could affect lipid metabolism
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Brotzu

OTHER

Sponsor Role collaborator

University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Sebastiano Banni

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sebastiano Banni, PhD

Role: PRINCIPAL_INVESTIGATOR

Università di Cagliari

Locations

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Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu

Cagliari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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unica

Identifier Type: -

Identifier Source: org_study_id

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