Role NLRP3 Inflammasome in Weight Loss Following Sleeve Gastrectomy in Morbidly Obese Patients

NCT04814147 | Unknown

• 1 other identifier: 18_RIPH3-14
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Epidemiological studies show a very rapid increase in the epidemic of obesity in the Caribbean population. 6 out of 10 adults are overweight and 1 out of 4 is obese. Most are women. Consequences : harm to health and possible reduction in life expectancy due to the association with many cardiovascular comorbidities. Adverse effects of obesity on the cardiovascular and endocrine systems are attributed a chronic low-grade inflammatory state in obese patients. Visceral adipose tissue is largely responsible for the inflammatory syndrome. Obesity can also induce the formation of multi-protein platforms called inflammasomes also activated by mitochondrial production. Morbid obesity treatment with sleeve gastrectomy is an effective long term therapeutic for weight loss but also beneficial in terms of insulin resistance and cardiovascular complications. Some patients nevertheless remain resistant to the beneficial cardio-metabolic effects of bariatric surgery. However, the mechanisms that regulate the extent of weight loss and its stabilization after bariatric surgery are still poorly understood. Our study aims to describe the evolution of postoperative weight loss and the place of preoperative inflammation in its amplitude. The hypothesis is that the level of inflammation in visceral fat before surgery determines the extent of postoperative weight loss in obese women who have undergone sleeve gastrectomy.

Conditions

Obesity Morbid; Obesity-Associated Insulin Resistance

Keywords

Obesity, cardiovascular risk, diabetes

Outcome Measures

Primary Outcomes (1)

• Weight loss (kg) at 12 months of sleeve gastrectomy

  Magnitude of weight loss (kg) at 12 months of sleeve gastrectomy as a function of the level of preoperative activation of the NLRP3 inflammasome.

  12 months

Secondary Outcomes (6)

• Preoperative activation level of the NLRP3 inflammasome

  1 day

• Mitochondrial activity

  1 day

• Pre and post operative inflammatory state

  24 months

• Pre and post-operative BMI

  24 months

• Pre and post-operative abdominal perimeter

  24 months

Interventions

Sleeve gastrectomy PROCEDURE

Measure of NLRP3 inflammasome preoperative activation level by the expression of NLRP3, IL-1β, IL18 and caspase-1 mRNAs in subcutaneous and visceral adipose tissue. of the epiploon;

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Due to the almost exclusive type of recruitment of obese women by the obesity management centre of CHU Martinique (around 90% of patients), only obese women aged between 18 and 45 years old will be included in the study. Only patients who have undergone a sleeve gastrectomy will be included in the study, as this surgical procedure is performed on approximately 9 out of 10 patients in the digestive surgery department of the CHU de Martinique.

You may qualify if:

• Being a woman between the ages of 18 and 45;
• Have been well informed about bariatric surgery and perioperative risks and have benefited from a multidisciplinary evaluation by a multidisciplinary team (RCP) ;
• Have a BMI greater than or equal to 40 kg/m2 or greater than or equal to 35 kg/m2 with at least one co-morbidity that can be improved after surgery (cardiovascular disease, sleep apnea and severe respiratory disorders, type 2 diabetes, osteoarticular diseases)
• Have been informed of the research on the samples taken during care;
• Having stated its decision not to object to the research on the samples taken during the treatment;
• To have accepted medical and surgical follow-up for 24 months;
• Patient under the general social security system.

You may not qualify if:

• Being a pregnant or nursing woman;
• Being a type 1 diabetic;
• Have inflammatory bowel disease;
• Have severe and unstable eating disorders ;
• Have severe, uncontrolled cognitive, mental or psychological disorders;
• Have a cancerous pathology;
• Be addicted to alcohol and psychoactive substances (both legal and illegal);
• Have a life-threatening illness in the short or medium term;
• Have contraindications related to surgical operations in general such as general anaesthesia;
• Be under legal protection measures (guardianship, curators, safeguarding of justice), and person deprived of liberty.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHU de Martinique

Fort-de-France, 97261, Martinique

RECRUITING

Related Publications (5)

• Neeland IJ, Poirier P, Despres JP. Cardiovascular and Metabolic Heterogeneity of Obesity: Clinical Challenges and Implications for Management. Circulation. 2018 Mar 27;137(13):1391-1406. doi: 10.1161/CIRCULATIONAHA.117.029617.

  PMID: 29581366 RESULT

• Vecchie A, Dallegri F, Carbone F, Bonaventura A, Liberale L, Portincasa P, Fruhbeck G, Montecucco F. Obesity phenotypes and their paradoxical association with cardiovascular diseases. Eur J Intern Med. 2018 Feb;48:6-17. doi: 10.1016/j.ejim.2017.10.020.

  PMID: 29100895 RESULT

• le Roux CW, Heneghan HM. Bariatric Surgery for Obesity. Med Clin North Am. 2018 Jan;102(1):165-182. doi: 10.1016/j.mcna.2017.08.011.

  PMID: 29156184 RESULT

• Pareek M, Schauer PR, Kaplan LM, Leiter LA, Rubino F, Bhatt DL. Metabolic Surgery: Weight Loss, Diabetes, and Beyond. J Am Coll Cardiol. 2018 Feb 13;71(6):670-687. doi: 10.1016/j.jacc.2017.12.014.

  PMID: 29420964 RESULT

• Lupoli R, Lembo E, Saldalamacchia G, Avola CK, Angrisani L, Capaldo B. Bariatric surgery and long-term nutritional issues. World J Diabetes. 2017 Nov 15;8(11):464-474. doi: 10.4239/wjd.v8.i11.464.

  PMID: 29204255 RESULT

Related Links

• WHO : obesity and overweight
• Overweight and abdominal obesity (KANNARI study in Martinique)

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Rémi NEVIERE, MD, PhD

  CHU de Martinique

  STUDY CHAIR

• Emmanuel RIVKINE

  CHU de Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyne CRASPAG, MSc

CONTACT

+596596592698; jocelyne.craspag@chu-martinique.fr

Study Design

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

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: March 24, 2021
• Study Start: March 13, 2021
• Primary Completion: June 13, 2024
• Study Completion: June 12, 2025
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)