MedDataX Logo

Nantes Bariatric Surgery Cohort

NCT ID: NCT06625762

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 :

1. Whether bariatric surgery is associated with changes in biological age
2. If bariatric surgery alters adipocyte dysfunction, the microbiota and biological rhythms
3. 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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study of the Nantes Bariatric Surgery Cohort (NBC) aims to evaluate the impact of bariatric surgery on biological age, adipocyte dysfunction, microbiota, and biological rhythms in individuals with obesity. This observational study will include 300 participants over 3.5 years. It involves pre-operative, peri-operative, and post-operative visits to collect clinical, biological, and lifestyle data. Key assessments include anthropometrics, blood tests, questionnaires, and biocollections

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Nantes bariatric surgery cohort

Intervention Type OTHER

The participants will be individuals living with obesity undergoing bariatric surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nantes bariatric surgery cohort

The participants will be individuals living with obesity undergoing bariatric surgery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David JACOBI, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

David JACOBI, PU-PH

Role: CONTACT

[email protected]
33 2 53 48 27 09

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

David JACOBI, PU-PH

Role: primary

[email protected]
33 2 53 48 27 09

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC23_0004

Identifier Type: -

Identifier Source: org_study_id