Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity

February 29, 2024 updated by: Parc de Salut Mar

Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity: Advancing Precision Medicine for the Treatment of Obesity

The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are:

  • Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery?
  • How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery?
  • What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery?

Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study conducted at the bariatric surgery unit. Patients undergo routine assessments and preoperative evaluations by a multidisciplinary team including surgeons, endocrinologists, nutritionists, psychologists, psychiatrists, and anesthesiologists. Clinical evaluations include physical examinations and laboratory tests to detect cardiometabolic comorbidities before surgery. The two bariatric surgery techniques performed in this center are gastric bypass and vertical gastrectomy. The choice of technique is based on clinical criteria and consensus of the multidisciplinary team. After surgery, patients are evaluated at 3, 6, and 12 months through anthropometry, blood pressure measurements, smoking habits assessment, and routine blood analysis. Patients are invited to participate in the OBEMAR registry during the preoperative period. With informed consent, patients authorize the collection of serum and plasma samples at each visit for scientific purposes. Participation in the study does not entail additional visits or procedures beyond standard clinical practice and participation in the OBEMAR registry.

Metabolically Health Status Criteria:

Health status will be defined according to the criteria used by Wildman et al. in the NHANES 1999-2004 study, excluding C-reactive protein measurement. Patients will be classified as metabolically healthy obese (OMS) if they have only one or none of the cardiometabolic factors. Patients with two or more risk factors will be categorized as metabolically unhealthy obese (OME). This classification will be performed before and one year after surgery.

Metabolomics The study will analyze various metabolites related to amino acid metabolism, energy metabolism, and lipid profile. These metabolites will provide insights into metabolic changes before and after bariatric surgery. Specifically, the study will focus on branched-chain amino acids (BCAA), aromatic amino acids (AAA), energy metabolites, and lipid species.

Sample size and origin To ensure statistical power, a sample size calculation was performed based on the anticipated distribution of patients transitioning to metabolically healthy obesity (OMS) or maintaining metabolically unhealthy obesity (OME) status after surgery. It is estimated that 84.4% of patients will transition to OMS, while the remaining 15.6% will remain OME after surgery. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-tailed test, a minimum of 19 subjects in the OME group and 102 in the OMS group are required to detect a difference of 25% or more in the selected metabolites. Assuming a common standard deviation of 35% for these metabolites, a total of 145 patients need to be included to ensure that 121 meet OME criteria before surgery.

Patients for this study will be sourced from the OBEMAR registry, which comprises individuals who have undergone bariatric surgery at the Hospital del Mar. A portion of the patients included in this registry already have sufficient clinical information to classify them as OMS or OME, and their biological samples are stored in a biobank. As of February 2023, complete clinical data and pre- and post-operative samples are available for 70 patients. With approximately 100 surgeries performed annually in our unit, it is anticipated that the desired sample size will be attained by July 2025.

Study Type

Observational

Enrollment (Estimated)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
        • Principal Investigator:
          • David Benaiges, PhD
        • Sub-Investigator:
          • Joan Pedro-Botet, PhD
        • Sub-Investigator:
          • Albert Goday, PhD
        • Sub-Investigator:
          • Carme Serra
        • Sub-Investigator:
          • Elisenda Climent, PhD
        • Sub-Investigator:
          • Helena Julià, PhD
        • Sub-Investigator:
          • Miguel Olano, MD
        • Sub-Investigator:
          • Oscar Pozo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients who have undergone bariatric surgery at the Hospital del Mar in Barcelona and meet the aforementioned inclusion criteria. These patients will be consecutively selected and must agree to participate in the study.

Description

Inclusion Criteria:

Patients undergoing bariatric surgery at the Hospital del Mar in Barcelona. Criteria for bariatric surgery are:

  • Ages between 18 and 60 years.
  • Body Mass Index (BMI) equal to or greater than 40, or equal to or greater than 35 kg/m2 with at least one obesity-related comorbidity (type 2 diabetes mellitus, hypertension, dyslipidemia, obstructive sleep apnea syndrome).
  • Previous failure with conventional treatment involving diet and exercise.

Exclusion Criteria:

  • History of previous bariatric surgery.
  • Presence of severe psychiatric disorders, severe eating disorders, alcohol or drug abuse.
  • Contraindications for major abdominal surgery, active gastric ulcer, severe liver disease.

Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Metabolic Signatures Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Analysis Predicting Transition from Metabolically Unhealthy Obesity (MUO) to Metabolically Healthy Obesity (MHO) Status
Time Frame: The transition from MUO to MHO status will be assessed at one year after bariatric surgery.

The primary objective of this study is to identify metabolic signatures present in patients with metabolically unhealthy obesity (MUO) before bariatric surgery, which can predict the transition to metabolically healthy obesity (MHO) status one year after the intervention.

For patients meeting the criteria for MUO before surgery, a comparison will be made between those who remain MUO at 12 months post-intervention and those who transition to MHO. The baseline metabolomic profile, measured using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), will be compared between these groups
The transition from MUO to MHO status will be assessed at one year after bariatric surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) between Patients with Persistent Metabolically Unhealthy Obesity (MUO) and Those Transitioning to Metabolically Healthy Obesity (MHO) Status
Time Frame: Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery
The secondary objective of this study is to compare the changes in metabolomic profiles between patients with persistent metabolically unhealthy obesity (MUO) and those who transition to metabolically healthy obesity (MHO) status one year after bariatric surgery. We aim to elucidate the metabolic pathways associated with successful metabolic health improvement following surgery.
Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery
Comparison of Baseline Metabolomic Profile and Its Evolution Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) after Surgery between Patients with Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUO)
Time Frame: Baseline metabolomic profiling will be conducted before surgery. The evolution of metabolomic profiles will be assessed at 3 and 12 months post-surgery.
This study aims to compare the baseline metabolomic profiles and their evolution after surgery between patients with metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO) using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) analysis. We will compare the metabolic signatures of patients classified as MHO and MUO before bariatric surgery. Specifically, we will compare the baseline metabolomic profiles and the changes in the metabolome at 3 and 12 months post-surgery. This analysis will provide insights into the metabolic mechanisms underlying metabolic health improvement after bariatric surgery.
Baseline metabolomic profiling will be conducted before surgery. The evolution of metabolomic profiles will be assessed at 3 and 12 months post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/11238/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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