Proteomic Analysis of Patients Undergoing Bariatric Surgery

January 16, 2025 updated by: Alvaro Ferraz, Universidade Federal de Pernambuco
The expression of proteins in the blood of obese individuals is different from the expression of proteins in healthy individuals, and is also different in individuals after bariatric surgery. Therefore, this research aims to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-operative status. The objective of this research is to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-surgery status.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to analyze the Proteomics of obese patients in the preoperative context of bariatric surgery to evaluate which are the up-regulated proteins - potentially related to oncogenic metabolic pathways - and also the down-regulated proteins in the context of obesity - potentially protective in the context of cancer. As well as, evaluate the variation of these proteins, as well as the metabolic pathways with which they are associated, after weight loss promoted by bariatric surgery, in the period of 01 year after this intervention.

The proteomic study will be carried out based on the formation of pools organized based on the patients' pre- and postoperative similarities. Proteomic analyzes will be carried out on a high-performance liquid chromatography system (nanoUPLC) model Acquity Mclass, Waters. Coupled to a Quadrupole Mass Spectrometer-Time of Flight (QToF) Model Sunapt Xs, Waters. Finally, the raw data (raw mass spectra) will be analyzed by the PROGENESIS QI software (Waters) to identify the proteins.

Study Type

Interventional

Enrollment (Estimated)

103

Phase

  • Not Applicable

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

  • Name: Luiz Henrique A Bandeira, Medicine student
  • Phone Number: 5581987082731
  • Email: luiz.bandeira@ufpe.br

Study Contact Backup

  • Name: Júlia M Lins, medicine student
  • Phone Number: 5581996906749
  • Email: julia.lins@upe.br

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670901
        • Hospital das clínicas da UFPE

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients over 18 years of age with a BMI above 35 kg/m² associated with comorbidity or BMI above 40 kg/m² without comorbidities,

Exclusion Criteria:

  • Patients with a previous history of cancer;
  • Underage patients
  • Patients with other diseases predisposing to the development of cancer: cirrhosis, ulcerative colitis, Barrett's esophagus, etc.
  • Patients who have previously undergone bariatric surgery;

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: women with insulin resistance
An analysis was made of patients with severe steatosis, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy
Experimental: patients with severe steatosis
An analysis was made of patients with severe steatosis, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy
Experimental: General patients with insulin resistance
An analysis was made of patients, among men and women, with insulin resistance, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy
Experimental: Patients with above average CRP
An analysis was carried out of patients with CRP above the average, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy
Experimental: Patients with grade 1 obesity
An analysis was made of patients with grade 1 obesity, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy
Experimental: Patients with grade 2 obesity
An analysis was made of patients with grade 2 obesity, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy
Experimental: Patients with grade 3 obesity
An analysis was made of patients with grade 3 obesity, among patients undergoing bariatric surgery
Procedure: bariatric surgery
sleeve gastrectomy
Other Names:
  • sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with reduced initially upregulated oncogenic proteins
Time Frame: 1 year after bariatric surgery
reduction of proteins potentially involved in oncogenic metabolic pathways, initially upregulated in the context of obesity
1 year after bariatric surgery

Collaborators and Investigators

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

Sponsor

Universidade Federal de Pernambuco

Investigators

  • Principal Investigator: Álvaro B Ferraz, Doctor, UFPE

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 (Estimated)

June 10, 2025

Primary Completion (Estimated)

September 9, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78992524100005208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are still checking pertinent information for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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