A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Obesity, Ulcerative Colitis
About this trial
This is an interventional treatment trial for Obesity focused on measuring ESG, IPAA
Eligibility Criteria
Inclusion Criteria: BMI 30-50 kg/m2 for at least 6 months prior to ESG Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA) Willing to adhere to the diet and behavior modifications required for ESG Able to follow the visit schedule Able to provide informed consent If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline Exclusion Criteria: Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG Current or recent (last six months) gastric or duodenal ulceration Esophageal or gastric varices Significant motility disorder of the esophagus or stomach Large hiatal hernia measuring >5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux Severe coagulopathy, hepatic insufficiency, or cirrhosis Gastric mass Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits Unwilling to participate in an established diet and behavior modification program, with routine follow-up Ongoing corticosteroid use at a dose of >5 mg daily Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision Alcohol or drug addiction Females who are pregnant, nursing, or planning pregnancy within the next year Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Sites / Locations
- Mayo Clinic MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Endoscopic Sleeve Gastroplasty (ESG)
Diet and Exercise
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
Participants receive lifestyle intervention only for 24 months