Nantes Bariatric Surgery Cohort

NCT06625762 | Not Yet Recruiting

• 1 other identifier: RC23_0004
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Biological aging; Adipocyte dysfunction; Biological rhythms

Outcome Measures

Primary Outcomes (1)

• Observe how biological age evolves between pre-bariatric surgery and 1 year after bariatric surgery

  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

Study Arms (1)

observation of the change in biological age after bariatric surgery

OTHER

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.

Other: Nantes bariatric surgery cohort

Interventions

Nantes bariatric surgery cohort OTHER

The participants will be individuals living with obesity undergoing bariatric surgery

observation of the change in biological age after bariatric surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Persons protected by law (guardianship or trusteeship) or deprived of their freedom,
• Pregnant women (contraindication to CB) or nursing mothers.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David JACOBI, PU-PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David JACOBI, PU-PH

CONTACT

33 2 53 48 27 09; david.jacobi@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 3, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 2, 2024

Record last verified: 2024-06

Locations

FR (1)