Investigating the NLRP3 Inflammasome's Role in Weight Loss After Sleeve Gastrectomy for Obese Patients

Role of NLRP3 Inflammasome Activation of Adipose Tissue in the Progression of Weight Loss After Sleeve Gastrectomy in Morbidly Obese Patients.

This study is trying to see how a specific part of the immune system affects weight loss in obese women after they have weight loss surgery called sleeve gastrectomy.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University Hospital Center of Martinique (Academic / other)
• Locations: 1 site (Fort-de-France)
• Trial ID: NCT04814147 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the role of the NLRP3 inflammasome in the weight loss outcomes of morbidly obese patients following sleeve gastrectomy. It focuses on understanding the mechanisms behind the varying responses to bariatric surgery, particularly in relation to insulin resistance and cardiovascular health. The study will involve women aged 18 to 45 with a BMI of 40 or higher, or 35 with related comorbidities, who have undergone a thorough evaluation and consented to participate. Data will be collected over a 24-month follow-up period to assess the long-term effects of the surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 45 with morbid obesity (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities).

Not a fit: Patients who are pregnant, nursing, have type 1 diabetes, or severe mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for patients who do not experience the expected benefits from bariatric surgery.

How similar studies have performed: While there have been studies on the effects of bariatric surgery, this specific investigation into the NLRP3 inflammasome's role is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Fort-de-France

• CHU de Martinique — Fort-de-France, Martinique (Recruiting)

Study contacts

• Principal investigator: Emmanuel RIVKINE — CHU de Martinique
• Study coordinator: Jocelyne CRASPAG, MSc

Conditions Obesity Morbid; Obesity-Associated Insulin Resistance; Obesity, cardiovascular risk, diabetes