ObesityNCT06787807
Proteomic Analysis of Patients Undergoing Bariatric Surgery
A study testing bariatric surgery in people with Obesity and Colon Cancer, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Colon Cancer, Thyroid Cancer
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients over 18 years of age with a BMI above 35 kg/m² associated with comorbidity or BMI above 40 kg/m² without comorbidities,
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Obesity, Colon Cancer, Thyroid Cancer, Esophageal Cancer, Pancreatic Cancer, Gastric Cancer
- Being tested
- bariatric surgery
- Keywords
- obesity, cancer, bariatric surgery, proteomics, biomarkers, mass spectrometry
- Medical subject headings
- Obesity, Colonic Neoplasms, Thyroid Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
Also called sleeve gastrectomy
sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| women with insulin resistance | Experimental | An analysis was made of patients with severe steatosis, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
| patients with severe steatosis | Experimental | An analysis was made of patients with severe steatosis, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
| General patients with insulin resistance | Experimental | An analysis was made of patients, among men and women, with insulin resistance, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
| Patients with above average CRP | Experimental | An analysis was carried out of patients with CRP above the average, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
| Patients with grade 1 obesity | Experimental | An analysis was made of patients with grade 1 obesity, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
| Patients with grade 2 obesity | Experimental | An analysis was made of patients with grade 2 obesity, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
| Patients with grade 3 obesity | Experimental | An analysis was made of patients with grade 3 obesity, among patients undergoing bariatric surgery Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reduced initially upregulated oncogenic proteins
reduction of proteins potentially involved in oncogenic metabolic pathways, initially upregulated in the context of obesity
Measured: 1 year after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start10 Jun 2025 (estimated)
- Primary completion9 Sep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Ferraz, Universidade Federal de Pernambuco
- Investigators
- Álvaro B Ferraz, Doctor, Principal investigator, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787807
- Sponsor's protocol ID
- 78992524100005208
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are still checking pertinent information for sharing
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06787807
- Acronym / sponsor ID
- 78992524100005208
- Conditions
- Obesity, Colon Cancer, Thyroid Cancer, Esophageal Cancer, Pancreatic Cancer, Gastric Cancer
- Keywords
- obesity, cancer, bariatric surgery, proteomics, biomarkers, mass spectrometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 9 Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| women with insulin resistance | Experimental | Procedure: bariatric surgeryAn analysis was made of patients with severe steatosis, among patients undergoing bariatric surgery |
| patients with severe steatosis | Experimental | Procedure: bariatric surgeryAn analysis was made of patients with severe steatosis, among patients undergoing bariatric surgery |
| General patients with insulin resistance | Experimental | Procedure: bariatric surgeryAn analysis was made of patients, among men and women, with insulin resistance, among patients undergoing bariatric surgery |
| Patients with above average CRP | Experimental | Procedure: bariatric surgeryAn analysis was carried out of patients with CRP above the average, among patients undergoing bariatric surgery |
| Patients with grade 1 obesity | Experimental | Procedure: bariatric surgeryAn analysis was made of patients with grade 1 obesity, among patients undergoing bariatric surgery |
| Patients with grade 2 obesity | Experimental | Procedure: bariatric surgeryAn analysis was made of patients with grade 2 obesity, among patients undergoing bariatric surgery |
| Patients with grade 3 obesity | Experimental | Procedure: bariatric surgeryAn analysis was made of patients with grade 3 obesity, among patients undergoing bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over 18 years of age with a BMI above 35 kg/m² associated with comorbidity or BMI above 40 kg/m² without comorbidities,
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgeryAlso: sleeve gastrectomysleeve gastrectomy | Procedure or surgery | General patients with insulin resistance, Patients with above average CRP, Patients with grade 1 obesity, Patients with grade 2 obesity, Patients with grade 3 obesity, patients with severe steatosis, women with insulin resistance |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided. We are still checking pertinent information for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Álvaro B Ferraz, Doctor principal investigator
UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bariatric surgery in people with Obesity and Colon Cancer, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luiz Henrique A Bandeira, Medicine student (5581987082731, luiz.bandeira@ufpe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with reduced initially upregulated oncogenic proteins (time frame: 1 year after bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.