The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty) — FULNESS  

Obesity Clinical Trial

Official title: A Pilot Study to Evaluate the Impact of Gastric Mucosal Ablation (GMA) of the Fundus With Hybrid Argon Plasma Coagulation (HybridAPC) Combined With Endoscopic Sleeve Gastroplasty (ESG) on Obesity

Status Recruiting

Clinical Trial Summary

Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.

Clinical Trial Description

Obesity is one of the most prevalent diseases worldwide with a major impact on the health care system in many countries. Bariatric surgery is currently the first treatment option in obese patients because it offers lasting results on body weight loss and reduces disease-related comorbidities. In recent years, however, endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective method in treating obese patients. Considering the lower complication rate compared with bariatric surgery and the greater weight loss compared with medical therapy, ESG finds indication as a treatment in cases of class I and II obesity. In cases of BMI > 40 or higher, bariatric surgery is actually the best option to achieve lasting weight loss but may be burdened by significant morbidity and mortality related to the surgery itself. Ghrelin is a potent oressigenic hormone produced and secreted mainly by the endocrine cells of the gastric glands at the bottom of the stomach and acts in the brain to regulate food intake. Gastric ghrelin plays a key role in glucose metabolism. Obese patients generally show reduced levels of ghrelin and a high percentage of these patients are insulin-resistant, have high circulating levels of insulin, hyperglycemia or diabetes. Through gene expression data and electron microscopy the activity of GPCs (ghrelin-like cells) could be increased in obese patients and correlates with glycemic levels. A positive correlation has been suggested between ghrelin gene expression, glycemic values and body mass index in obese patients. Taken together, these data indicate that ghrelin overproduction by the stomach may be involved in the weight gain and pathogenesis of type 2 diabetes in obese patients. This study aims to demonstrate how further ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. Indeed, HybridAPC could stimulate fundus stem cells to produce new ghrelin-secreting endocrine cells with normal secretory activity as in lean subjects. Thus normalizing ghrelin signaling to appetite/hunger areas in the brain relayed through the gut brain axis. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT06438510
• Study type: Interventional
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Ivo Boskoski
• Phone: +390630156580
• Email: ivo.boskoski@policlinicogemelli.it
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2023
• Completion date: June 1, 2025