Periodontal Microbiota of Patients Candidates for Bariatric Surgery with Body Mass Index Greater Than 30

NCT06781229 | Not Yet Recruiting

• 1 other identifier: RC31/24/0432
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to compare the microbiological composition of the periodontal plaque of obese people undergoing bariatric surgery according to their Body Mass Index. The main question it aims to answer is: Does obese patients have different microbiote according to their obesity? Obesity being classified in two groups :

• group "obesity" for a BMI between 30 and 35
• versus "morbid obesity" group with a BMIabove 35. Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will answer questions about their quality of life, hygiene habits, and saliva and periodontal samples will be taken.

Conditions

Bariatric Surgery; Obesity, Morbid

Keywords

microbiological composition; obese; bypass; Body mass index

Outcome Measures

Primary Outcomes (1)

• Taxonomic analysis

  Taxonomic analysis of the microbiological composition of the periodontal plaque between group 1 (obesity) and 2 (morbid obesity) : relative quantities of periodontal bacteria between group 1 (obesity) and 2 (morbid obesity)

  before bariatric surgery

Study Arms (2)

Group 1 : obesity : 30 ≤ BMI < 35

Obese patients with 30 ≤ BMI \< 35

Group 2 : morbid obesity : 35 ≤ BMI

Morbid obese patients with 35 ≤ BMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients scheduled to undergo bariatric surgery

You may qualify if:

• BMI greater than or equal to 30
• Be on the list of patients scheduled for bariatric surgery,
• Be able to receive information about the study and understand the information form in order to take part in the study. This implies mastering the French language,

You may not qualify if:

• Alcohol consumption \>30g/d (men) or 20g/d (women),
• During pregnancy or breastfeeding,
• At risk of infection (existence of one or more of the following known chronic infectious diseases: HIV, HBV, HCV and mononucleosis) and/or chronic renal insufficiency (creatinine clearance \< 60ml/min),
• Patients with a general pathology that contraindicates the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the ANSM).
• Totally edentulous patients

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Biospecimen

Retention: SAMPLES WITH DNA

* 5g of visceral adipose tissue and 5g of subcutaneous adipose tissue * Saliva samples * Samples of periodontal plaque in the periodontal sulcus (assessed during partial probing) using sterile paper points (minimum 3 and maximum 10 per patient) inserted for 30 seconds into the periodontal sulcus.

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Stephanie BRAYER, Clinical Trial Assistant, master's degree

CONTACT

0561322509; Brayer.Stephanie@iuct-oncopole.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 17, 2025

Record last verified: 2025-01