nctId: NCT06305208 id: CCLR-23-018 briefTitle: A UK Registry for Metabolic and Bariatric Endoscopic Interventions acronym: UK-ENDOMAB overallStatus: RECRUITING date: 2024-02-01 date: 2034-02-01 date: 2039-02-01 date: 2024-03-12 date: 2024-03-15 name: Cleveland Clinic London class: OTHER 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. conditions: Obesity conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Endoscopic gastric suturing name: Endoscopic gastric plication name: Revisional gastroplasty name: Transoral outlet reduction endoscopy (TORe) name: Duodenal mucosal resurfacing (DMR) name: Intragastric balloon(s) measure: Total body weight loss percentage (TBWL%) measure: Change in glycated haemoglobin (HbA1c; mmol/mol) measure: Change in the number and dose of anti-diabetic medications measure: Procedure time (mins) measure: Inpatient stay (days) measure: Adverse events measure: Change in systolic blood pressure measurements (mmHg) measure: Change in diastolic blood pressure measurements (mmHg) measure: Changes in number and dose of anti-hypertensive medications (n) measure: Changes in low-density lipoprotein cholesterol (mmol/L) measure: Changes in triglycerides (mmol/L) measure: Changes in high-density lipoprotein cholesterol (mmol/L) measure: Changes in total cholesterol (mmol/L) measure: Changes in alanine transaminase (IU/L) measure: Changes in aspartate aminotransferase (IU/L) measure: Changes in Fibrosis-4 Index for Liver Fibrosis measure: Changes in non-alcoholic fatty liver disease fibrosis score measure: Changes in weight (kg) measure: Changes in body mass index (kg/m2) measure: Changes in glycated haemoglobin (HbA1c; mmol/mol) measure: Changes in number and dose of anti-diabetic medications (n) measure: Changes in number and dose of anti-obesity medications (n) measure: Changes in health-related quality of life scores (EuroQol-5D-5L) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic London status: RECRUITING city: London zip: SW1X 7HY country: United Kingdom name: Benjamin Norton, MD role: CONTACT email: cclendoscopyresearch@ccf.org name: Rehan Haidry, MD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False