Clinical trial NCT06305208: A UK Registry for Metabolic and Bariatric Endoscopic Interventions
Official title: A UK Registry for Metabolic and Bariatric Endoscopic Interventions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Diabetes Mellitus, Type 2
Lead sponsor: Cleveland Clinic London
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients within the United Kingdom (UK) who have, or plan to, undergo a primary or revisional bariatric or metabolic endoscopic procedure for the treatment of obesity or metabolic disease in the UK

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
* Age ≥ 18 years old
* Able to give written informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Total body weight loss percentage (TBWL%)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Change in glycated haemoglobin (HbA1c; mmol/mol)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Change in the number and dose of anti-diabetic medications
timeFrame: 6-months, 1-, 2-, 3-, 5-years
Secondary outcomes:
measure: Procedure time (mins)
timeFrame: Baseline
measure: Inpatient stay (days)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Adverse events
timeFrame: 30-day, 6-months, 1-, 2-, 3-, 5-years
measure: Change in systolic blood pressure measurements (mmHg)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Change in diastolic blood pressure measurements (mmHg)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in number and dose of anti-hypertensive medications (n)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in low-density lipoprotein cholesterol (mmol/L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in triglycerides (mmol/L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in high-density lipoprotein cholesterol (mmol/L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in total cholesterol (mmol/L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in alanine transaminase (IU/L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in aspartate aminotransferase (IU/L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in Fibrosis-4 Index for Liver Fibrosis
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in non-alcoholic fatty liver disease fibrosis score
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in weight (kg)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in body mass index (kg/m2)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in glycated haemoglobin (HbA1c; mmol/mol)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in number and dose of anti-diabetic medications (n)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in number and dose of anti-obesity medications (n)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
measure: Changes in health-related quality of life scores (EuroQol-5D-5L)
timeFrame: 6-months, 1-, 2-, 3-, 5-years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Cleveland Clinic London
Study officials:
affiliation: Cleveland Clinic London
name: Rehan Haidry, MD
role: PRINCIPAL_INVESTIGATOR
References: