Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

July 28, 2021 updated by: Sebastiano Banni, University of Cagliari

Characterization of Physiological Mechanisms Involved in the Regulation of Eating Behavior for the Identification of Innovative Nutritional Strategies for Obese Patients Before and After Bariatric Surgery

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Cagliari, Italy
    - Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for bariatric surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modifications of Endocannabinoid and N-acylethanolamine plasma levels Time Frame: 6 months	These lipid derivatives are involved in control of energy expenditure and lipid metabolism and are measured by LC MS/MS and expressed as nmol/ml plasma	6 months
Weight loss as kg, and fat mass reduction as total kg and percent of body mass Time Frame: 6 months	Indicators of the success of the intervention	6 months
Changes in fatty acid plasma profile induced by bariatric surgery Time Frame: 6 months	Fatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Collaborators

Azienda Ospedaliera Brotzu

Investigators

Principal Investigator: Sebastiano Banni, PhD, Università di Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

September 7, 2020

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)