NCT06616714

Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease

Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and inflammatoRy Bowel Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Laterza Lucrezia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Obesity is classified as a body mass index (BMI) above 30 kg/m2 by the World Health Organization. Both overweight (BMI \> 25 kg/m2) and obesity (BMI \>30 kg/m2) have increased worldwide during the last decades: 1.46 billion of the adult population were estimated to be overweight in 2008, particularly 205 million men and 297 millions of women were estimated to be obese. Obesity is associated with lower quality of life and is linked to serious comorbidities such as type 2 diabetes mellitus, hypertension, cardiovascular diseases and several cancers. Furthermore, obesity is significantly linked to a higher mortality risk compared to normal weight individuals. Obesity is also significantly increasing in patients with IBD. Obesity enhances the inflammatory activity in IBD, leads to longer hospitalization, and increases the possibility to develop extra intestinal manifestations. Also, the frequency of having extended systemic steroid treatment and use of antibiotics seems greater in IBD patients with obesity. Hence, treatment and prevention of obesity, especially in IBD patients, should have high priority.

Detailed description

This is a single center, observational, prospective clinical study. ESG is a procedure commonly performed in our center thus only patients who have indication to ESG for clinical reasons will be included and ESG will be performed as per clinical practice. Follow-up of the enrolled patients will be planned according to the routine follow-up for patients with IBD regarding timing and laboratory procedures. All participants will undergo a lifestyle modification treatment, nutritional and psychological support as per clinical standard of practice. Investigators and study personnel from the study site will ensure that equal instructions for diet, physical activity, laboratory analysis and other procedures will be used for each patient. All patients will also perform ESG within 90 days after the enrollment and they will be followed-up for 12 months after ESG. Patients will be evaluated before, immediately after and at 1, 3, 6 and 12 months after ESG. The total duration of this study will be about 27 months. It will take place at Fondazione Policlinico Universitario A. Gemelli IRCCS, CEMAD unit and Digestive Endoscopy unit.

Conditions

• Inflammatory Bowel Diseases
• Obesity

Interventions

Type	Name	Description
OTHER	Observtional Study	Observtional Study

Timeline

• Start date: 2024-05-20
• Primary completion: 2026-05-20
• Completion: 2027-05-20
• First posted: 2024-09-27
• Last updated: 2024-10-01

Locations

1 site across 1 country: Italy