Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616714
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-16
Brief Title:
Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and inflammatoRy Bowel Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOWER
Brief Summary:
Obesity is classified as a body mass index BMI above 30 kgm2 by the World Health Organization Both overweight BMI 25 kgm2 and obesity BMI 30 kgm2 have increased worldwide during the last decades 146 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None