Lipid Metabolism in Obese Subjects Undergoing 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.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu

Cagliari, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

Azienda Ospedaliera Brotzu

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Aug 2, 2021
Registry last updated: Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed