Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297928
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-22
Brief Title:
Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity Advancing Precision Medicine for the Treatment of Obesity
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 844 of patients will transition to OMS while the remaining 156 will remain OME after surgery Accepting an alpha risk of 005 and a beta risk of 02 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
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 844 of patients will transition to OMS while the remaining 156 will remain OME after surgery Accepting an alpha risk of 005 and a beta risk of 02 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None