Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

NCT04984785 | Completed

• 1 other identifier: unica
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Lipid Metabolism Disorders; Obesity

Keywords

Fatty Acids, Nonesterified; Peroxisome Proliferator-Activated Receptors; Endocannabinoids; N-acylethanolamines

Outcome Measures

Primary Outcomes (3)

• Modifications of Endocannabinoid and N-acylethanolamine plasma levels

  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

  Indicators of the success of the intervention

  6 months

• Changes in fatty acid plasma profile induced by bariatric surgery

  Fatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for bariatric surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead
• Azienda Ospedaliera Brotzu: collaborator

Study Sites (1)

Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu

Cagliari, Italy

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders; Obesity

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastiano Banni, PhD

  Università di Cagliari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: August 2, 2021
• Study Start: February 1, 2019
• Primary Completion: November 4, 2019
• Study Completion: September 7, 2020
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)