- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06625762
Nantes Bariatric Surgery Cohort (NBC)
While current research suggests that inflammation of adipose tissue in obesity is linked to accelerated aging, it has yet to be determined in humans how this could enhance preventative and personalized medicine for obese individuals. The NBC study aims to investigate :
- Whether bariatric surgery is associated with changes in biological age
- If bariatric surgery alters adipocyte dysfunction, the microbiota and biological rhythms
- Whether changes in adipocyte dysfunction, microbiota and biological rhythms are linked to changes in biological age.
To achieve this, establishing a biocollection before, during and after bariatric surgery will be crucial in addressing these questions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David JACOBI, PU-PH
- Phone Number: 33 2 53 48 27 09
- Email: david.jacobi@chu-nantes.fr
Study Locations
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, France, 44093
- Recruiting
- Nantes University Hospital
-
Contact:
- David JACOBI, PU-PH
- Phone Number: 33 2 53 48 27 09
- Email: david.jacobi@chu-nantes.fr
-
Principal Investigator:
- David JACOBI, PU-PH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria :
Individuals selected for bariatric surgery (starting the BC pathway within the Nantes University Hospital bariatric unit). Inclusion criteria are those of the Bariatric Surgery program.
- male or female, adult over 18 years of age
- BMI ≥ 35 kg/m2 with complication(s) or ≥ 40 kg/m2 with or without complication (the list of eligible complications is referenced in HAS 2024 recommendations). In the event of a change in access to bariatric surgery, this threshold could be revised without any substantial change to the protocol.
- having consented to their participation in the cohort
- participant affiliated to or benefiting from a social security scheme
Exclusion Criteria :
- Persons protected by law (guardianship or trusteeship) or deprived of their freedom,
- Pregnant women (contraindication to CB) or nursing mothers.
Study Plan
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 |
|---|---|
|
Other: observation of the change in biological age after bariatric surgery
Patients over 18 years of age suffering from obesity and requiring bariatric surgery. Evolution of biological age 1 year after surgery, defined by the difference between age biological at TPO and TAC 1 year, estimated by measuring the phenotypic age, itself determined from the following eight variables: albumin; creatinine; fasting blood sugar; CRP ; lymphocyte count; mean corpuscular volume of red blood cells; Anisocytosis index of red blood cells; alkaline phosphatases; leukocyte rate. |
The participants will be individuals living with obesity undergoing bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observe how biological age evolves between pre-bariatric surgery and 1 year after bariatric surgery
Time Frame: 1 year
|
Biological age will be estimated by measuring phenotypic age.
The phenotypic age will be determined from the following variable: albumin, creatinine, fasting glucose, CRP, lymphocyte count, red cell size, alkaline phosphates, leukocyte count.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David JACOBI, PU-PH, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC23_0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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