protocolSection identificationModule nctId: NCT06305208, orgStudyIdInfo id: CCLR-23-018, briefTitle: A UK Registry for Metabolic and Bariatric Endoscopic Interventions, acronym: UK-ENDOMAB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2034-02-01, completionDateStruct date: 2039-02-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Cleveland Clinic London, class: OTHER, descriptionModule briefSummary: In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments., conditionsModule conditions: Obesity, conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic gastric suturing, interventions name: Endoscopic gastric plication, interventions name: Revisional gastroplasty, interventions name: Transoral outlet reduction endoscopy (TORe), interventions name: Duodenal mucosal resurfacing (DMR), interventions name: Intragastric balloon(s), outcomesModule primaryOutcomes measure: Total body weight loss percentage (TBWL%), primaryOutcomes measure: Change in glycated haemoglobin (HbA1c; mmol/mol), primaryOutcomes measure: Change in the number and dose of anti-diabetic medications, secondaryOutcomes measure: Procedure time (mins), secondaryOutcomes measure: Inpatient stay (days), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Change in systolic blood pressure measurements (mmHg), secondaryOutcomes measure: Change in diastolic blood pressure measurements (mmHg), secondaryOutcomes measure: Changes in number and dose of anti-hypertensive medications (n), secondaryOutcomes measure: Changes in low-density lipoprotein cholesterol (mmol/L), secondaryOutcomes measure: Changes in triglycerides (mmol/L), secondaryOutcomes measure: Changes in high-density lipoprotein cholesterol (mmol/L), secondaryOutcomes measure: Changes in total cholesterol (mmol/L), secondaryOutcomes measure: Changes in alanine transaminase (IU/L), secondaryOutcomes measure: Changes in aspartate aminotransferase (IU/L), secondaryOutcomes measure: Changes in Fibrosis-4 Index for Liver Fibrosis, secondaryOutcomes measure: Changes in non-alcoholic fatty liver disease fibrosis score, secondaryOutcomes measure: Changes in weight (kg), secondaryOutcomes measure: Changes in body mass index (kg/m2), secondaryOutcomes measure: Changes in glycated haemoglobin (HbA1c; mmol/mol), secondaryOutcomes measure: Changes in number and dose of anti-diabetic medications (n), secondaryOutcomes measure: Changes in number and dose of anti-obesity medications (n), secondaryOutcomes measure: Changes in health-related quality of life scores (EuroQol-5D-5L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic London, status: RECRUITING, city: London, zip: SW1X 7HY, country: United Kingdom, contacts name: Benjamin Norton, MD, role: CONTACT, email: cclendoscopyresearch@ccf.org, contacts name: Rehan Haidry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False