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Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04984785
Enrollment
68
Registered
2021-08-02
Start date
2019-02-01
Completion date
2020-09-07
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Lipid Metabolism Disorders, Obesity

Keywords

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

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

Interventions

None listed

Sponsors

Azienda Ospedaliera Brotzu
CollaboratorOTHER
University of Cagliari
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modifications of Endocannabinoid and N-acylethanolamine plasma levels6 monthsThese 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 mass6 monthsIndicators of the success of the intervention
Changes in fatty acid plasma profile induced by bariatric surgery6 monthsFatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026