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NCT Number: NCT06305208

A UK Registry for Metabolic and Bariatric Endoscopic Interventions

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic London

London, SW1X 7HY, United Kingdom

Location status: Recruiting

Location contact

Benjamin Norton, MD

CONTACT

[email protected]

Rehan Haidry, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic gastric suturing

Device

Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system.

Other names: Endoscopic sleeve gastroplasty (ESG; Apollo Overstitch)

Endoscopic gastric plication

Device

Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.

Other names: Primary obesity surgery endoluminal (POSE), Endomina system

Revisional gastroplasty

Device

Endoscopic suturing or plication of the stomach among patients who have previously undergone gastroplasty, sleeve gastrectomy, or Roux-en-Y gastric bypass to restrict the stomach and promote weight loss

Transoral outlet reduction endoscopy (TORe)

Device

Reduction of the size of the gastro-jejunal anastomosis among patients who have previously undergone Roux-en-Y gastric bypass to promote weight loss. A variety of techniques may be used alone or in isolation including suturing (Apollo Overstitch), plication (POSE), argon photocoagulation, and endoscopic submucosal resection/dissection.

Duodenal Mucosal Resurfacing (DMR)

Device

Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes.

Intragastric balloon(s)

Device

The insertion of an intragastric implant into the stomach, which is subsequently filled with air or water to promote weight loss. Several intragastric balloons are available including Allurion, Heliosphere, Obalon, Orbera, and Spatz.

Primary outcomes

  1. Total body weight loss percentage (TBWL%)

    Time frame: 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

  2. Change in glycated haemoglobin (HbA1c; mmol/mol)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

    For primary metabolic procedures

  3. Change in the number and dose of anti-diabetic medications

    Time frame: 6-months, 1-, 2-, 3-, 5-years

    For primary metabolic procedures

Secondary outcomes

  1. Procedure time (mins)

    Time frame: Baseline

  2. Inpatient stay (days)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  3. Adverse events

    Time frame: 30-day, 6-months, 1-, 2-, 3-, 5-years

  4. Change in systolic blood pressure measurements (mmHg)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  5. Change in diastolic blood pressure measurements (mmHg)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  6. Changes in number and dose of anti-hypertensive medications (n)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  7. Changes in low-density lipoprotein cholesterol (mmol/L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  8. Changes in triglycerides (mmol/L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  9. Changes in high-density lipoprotein cholesterol (mmol/L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  10. Changes in total cholesterol (mmol/L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  11. Changes in alanine transaminase (IU/L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  12. Changes in aspartate aminotransferase (IU/L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  13. Changes in Fibrosis-4 Index for Liver Fibrosis

    Time frame: 6-months, 1-, 2-, 3-, 5-years

    The Fibrosis-4 Index for Liver Fibrosis provides a probability score for the presence of hepatic fibrosis. It is based on age, ALT, AST, and platelet count. The range of the score is wide but there are two main cut-offs point for prediction of advanced fibrosis (<1.3 and >2.67). Higher scores indicate a higher likelihood of advanced fibrosis.

  14. Changes in non-alcoholic fatty liver disease fibrosis score

    Time frame: 6-months, 1-, 2-, 3-, 5-years

    The non-alcoholic fatty liver disease fibrosis score provides a probability score for the presence of hepatic fibrosis. It is based on age, body mass index, impaired fasting glucose, ALT, AST, albumin and platelet count. The range of the score is wide but there are two main cut-offs for prediction of advanced fibrosis (<-1.455 and >0.676). Higher scores indicate a higher likelihood of advanced fibrosis.

  15. Changes in weight (kg)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  16. Changes in body mass index (kg/m2)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  17. Changes in glycated haemoglobin (HbA1c; mmol/mol)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  18. Changes in number and dose of anti-diabetic medications (n)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  19. Changes in number and dose of anti-obesity medications (n)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

  20. Changes in health-related quality of life scores (EuroQol-5D-5L)

    Time frame: 6-months, 1-, 2-, 3-, 5-years

    The EuroQol-5D-5L is a quality of life questionnaire that is composed of five questions scored 1-5 that do not have an arithmetic value and a visual analogue scale between 0-100. Participants are simply given a five digit code (e.g. 13455) and a visual analogue score (e.g. 78), which can then be interpreted through reference value sets in the corresponding country.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Norton, MD

CONTACT

[email protected]

+442034237500

Fiona Makia

CONTACT

[email protected]

+442034237500

Sponsors and collaborators

Lead sponsor

Cleveland Clinic London

Other

Registry information

Acronym: UK-ENDOMAB

Important dates

Study start
2024
Primary completion
2034
Study completion
2039
First posted
Mar 12, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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