A UK Registry for Metabolic and Bariatric Endoscopic Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in glycated haemoglobin (HbA1c; mmol/mol)
研究概览
简要总结
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.
详细描述
This is a national, multi-centre, prospective, UK registry that aims to determine the safety and efficacy of metabolic and bariatric endoscopic procedures used in the treatment of obesity and related complications. The investigators will do this by determining the effect of primary bariatric procedures (gastroplasty, intragastric balloons (IGB)), revisional bariatric procedures (Transoral outlet reduction endoscopy (TORe), gastroplasty revision), and primary metabolic procedures (Duodenal Mucosal Resurfacing (DMR)), completed by endoscopists within the UK.
The objective of this registry is to collect demographic, procedural and follow-up outcome data on the use of metabolic and bariatric endoscopic procedures in patients with obesity and/or obesity-related complications. This registry will provide real-life outcomes on the use of these novel endoscopic devices from multiple centres participating across the UK to provide longer-term safety and efficacy data. In addition, the registry will enable development of a UK-wide research network to support further research, innovation, and training into metabolic and bariatric endoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
- •Age ≥ 18 years old
- •Able to give written informed consent.
排除标准
- •Any bariatric or metabolic endoscopic procedure performed outside the UK.
- •Any bariatric or metabolic endoscopic procedure not currently listed within the registry protocol or agreed by the steering committee.
- •Unable to provide written informed consent.
结局指标
主要结局
Change in glycated haemoglobin (HbA1c; mmol/mol)
时间窗: 6-months, 1-, 2-, 3-, 5-years
For primary metabolic procedures
Total body weight loss percentage (TBWL%)
时间窗: 6-months, 1-, 2-, 3-, 5-years
For primary or revisional bariatric procedures: Percentage weight loss will be calculated using the following formula: TBWL% = \[(weight at the baseline-weight at the end of time period)/weight at baseline\] x 100
Change in the number and dose of anti-diabetic medications
时间窗: 6-months, 1-, 2-, 3-, 5-years
For primary metabolic procedures
次要结局
- Changes in number and dose of anti-hypertensive medications (n)(6-months, 1-, 2-, 3-, 5-years)
- Change in diastolic blood pressure measurements (mmHg)(6-months, 1-, 2-, 3-, 5-years)
- Changes in triglycerides (mmol/L)(6-months, 1-, 2-, 3-, 5-years)
- Changes in low-density lipoprotein cholesterol (mmol/L)(6-months, 1-, 2-, 3-, 5-years)
- Changes in non-alcoholic fatty liver disease fibrosis score(6-months, 1-, 2-, 3-, 5-years)
- Inpatient stay (days)(6-months, 1-, 2-, 3-, 5-years)
- Adverse events(30-day, 6-months, 1-, 2-, 3-, 5-years)
- Procedure time (mins)(Baseline)
- Changes in total cholesterol (mmol/L)(6-months, 1-, 2-, 3-, 5-years)
- Changes in glycated haemoglobin (HbA1c; mmol/mol)(6-months, 1-, 2-, 3-, 5-years)
- Changes in number and dose of anti-diabetic medications (n)(6-months, 1-, 2-, 3-, 5-years)
- Changes in aspartate aminotransferase (IU/L)(6-months, 1-, 2-, 3-, 5-years)
- Change in systolic blood pressure measurements (mmHg)(6-months, 1-, 2-, 3-, 5-years)
- Changes in high-density lipoprotein cholesterol (mmol/L)(6-months, 1-, 2-, 3-, 5-years)
- Changes in alanine transaminase (IU/L)(6-months, 1-, 2-, 3-, 5-years)
- Changes in weight (kg)(6-months, 1-, 2-, 3-, 5-years)
- Changes in number and dose of anti-obesity medications (n)(6-months, 1-, 2-, 3-, 5-years)
- Changes in Fibrosis-4 Index for Liver Fibrosis(6-months, 1-, 2-, 3-, 5-years)
- Changes in health-related quality of life scores (EuroQol-5D-5L)(6-months, 1-, 2-, 3-, 5-years)
- Changes in body mass index (kg/m2)(6-months, 1-, 2-, 3-, 5-years)