Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984785
• Other study ID #: unica
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: September 7, 2020

Study information

• Verified date: July 2021
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 7, 2020
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Lipid Metabolism Disorders
• Metabolic Diseases
• Obesity

Locations

Country	Name	City	State
Italy	Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu	Cagliari

Sponsors (2)

Lead Sponsor	Collaborator
University of Cagliari	Azienda Ospedaliera Brotzu

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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