Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

Completed

• Conditions: Lipid Metabolism Disorders; Bariatric Surgery Candidate; Obesity

• Registration Number: NCT04984785
• Lead Sponsor: University of Cagliari

Brief Summary

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

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 Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-11-04
• Study Completion: 2020-09-07
• Study First Submitted: 2021-05-31
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modifications of Endocannabinoid and N-acylethanolamine plasma levels	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
Weight loss as kg, and fat mass reduction as total kg and percent of body mass	6 months	Indicators of the success of the intervention
Changes in fatty acid plasma profile induced by bariatric surgery	6 months	Fatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma

Trial Locations

Locations (1)

Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu; 🇮🇹 Cagliari, Italy