ObesityUK-ENDOMABNCT06305208
A UK Registry for Metabolic and Bariatric Endoscopic Interventions
An observational study of Obesity and Diabetes Mellitus, Type 2, run by Cleveland Clinic London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Endoscopic gastric suturing, Endoscopic gastric plication and Revisional gastroplasty
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2024to 1 Feb 2039
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
- Age ≥ 18 years old
- Able to give written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cleveland Clinic London
London, SW1X 7HY
Benjamin Norton, MD, cclendoscopyresearch@ccf.org
Rehan Haidry, MD
About this study
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.
Read the 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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Endoscopic gastric suturing, Endoscopic gastric plication, Revisional gastroplasty, Transoral outlet reduction endoscopy (TORe), Duodenal mucosal resurfacing (DMR)
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic gastric suturingDevice
Also called Endoscopic sleeve gastroplasty (ESG; Apollo Overstitch)
Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system.
Endoscopic gastric plicationDevice
Also called Primary obesity surgery endoluminal (POSE), Endomina system
Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.
Revisional gastroplastyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary bariatric endoscopic procedures | Not described Receives: Device: Endoscopic gastric suturing; Device: Endoscopic gastric plication; Device: Intragastric balloon(s) | |
| Revisional bariatric endoscopic procedures | Not described Receives: Device: Revisional gastroplasty; Device: Transoral outlet reduction endoscopy (TORe) | |
| Primary metabolic endoscopic procedures | Not described Receives: Device: Duodenal mucosal resurfacing (DMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body weight loss percentage (TBWL%)
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
Measured: 6-months, 1-, 2-, 3-, 5-years
Change in glycated haemoglobin (HbA1c; mmol/mol)
For primary metabolic procedures
Measured: 6-months, 1-, 2-, 3-, 5-years
Change in the number and dose of anti-diabetic medications
For primary metabolic procedures
Measured: 6-months, 1-, 2-, 3-, 5-years
Secondary outcomes (20)
Procedure time (mins)
Measured: Baseline
Inpatient stay (days)
Measured: 6-months, 1-, 2-, 3-, 5-years
Adverse events
Measured: 30-day, 6-months, 1-, 2-, 3-, 5-years
Change in systolic blood pressure measurements (mmHg)
Measured: 6-months, 1-, 2-, 3-, 5-years
Change in diastolic blood pressure measurements (mmHg)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-hypertensive medications (n)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in low-density lipoprotein cholesterol (mmol/L)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in triglycerides (mmol/L)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in high-density lipoprotein cholesterol (mmol/L)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in total cholesterol (mmol/L)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in alanine transaminase (IU/L)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in aspartate aminotransferase (IU/L)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in Fibrosis-4 Index for Liver Fibrosis
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.
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in non-alcoholic fatty liver disease fibrosis score
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.
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in weight (kg)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in body mass index (kg/m2)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in glycated haemoglobin (HbA1c; mmol/mol)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-diabetic medications (n)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-obesity medications (n)
Measured: 6-months, 1-, 2-, 3-, 5-years
Changes in health-related quality of life scores (EuroQol-5D-5L)
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.
Measured: 6-months, 1-, 2-, 3-, 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2034 (estimated)
- Study completion1 Feb 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rehan Haidry, MD, Principal investigator, Cleveland Clinic London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305208
- Sponsor's protocol ID
- CCLR-23-018
- Acronym
- UK-ENDOMAB
- Status last verified
- Dec 2023
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A UK Registry for Metabolic and Bariatric Endoscopic Interventions
- ClinicalTrials.gov ID
- NCT06305208
- Acronym / sponsor ID
- UK-ENDOMAB / CCLR-23-018
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cleveland Clinic LondonUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2034 (estimated)
- Study completion
- 1 Feb 2039 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary bariatric endoscopic procedures | – | Device: Endoscopic gastric suturing, Device: Endoscopic gastric plication, Device: Intragastric balloon(s) |
| Revisional bariatric endoscopic procedures | – | Device: Revisional gastroplasty, Device: Transoral outlet reduction endoscopy (TORe) |
| Primary metabolic endoscopic procedures | – | Device: Duodenal mucosal resurfacing (DMR) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
- Age ≥ 18 years old
- Able to give written informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic gastric suturingAlso: Endoscopic sleeve gastroplasty (ESG; Apollo Overstitch)Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system. | Device | Primary bariatric endoscopic procedures |
| Endoscopic gastric plicationAlso: Primary obesity surgery endoluminal (POSE), Endomina systemEndoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system. | Device | Primary bariatric endoscopic procedures |
| Revisional gastroplastyEndoscopic 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 | Device | Revisional bariatric endoscopic procedures |
| Transoral outlet reduction endoscopy (TORe)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. | Device | Revisional bariatric endoscopic procedures |
| Duodenal mucosal resurfacing (DMR)Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes. | Device | Primary metabolic endoscopic procedures |
| Intragastric balloon(s)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. | Device | Primary bariatric endoscopic procedures |
Primary outcome
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
Change in glycated haemoglobin (HbA1c; mmol/mol)
Time frame: 6-months, 1-, 2-, 3-, 5-years
For primary metabolic procedures
Change in the number and dose of anti-diabetic medications
Time frame: 6-months, 1-, 2-, 3-, 5-years
For primary metabolic procedures
20 secondary outcomes
Procedure time (mins)
Time frame: Baseline
Inpatient stay (days)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Adverse events
Time frame: 30-day, 6-months, 1-, 2-, 3-, 5-years
Change in systolic blood pressure measurements (mmHg)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Change in diastolic blood pressure measurements (mmHg)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-hypertensive medications (n)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in low-density lipoprotein cholesterol (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in triglycerides (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in high-density lipoprotein cholesterol (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in total cholesterol (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in alanine transaminase (IU/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in aspartate aminotransferase (IU/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in Fibrosis-4 Index for Liver Fibrosis
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in non-alcoholic fatty liver disease fibrosis score
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in weight (kg)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in body mass index (kg/m2)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in glycated haemoglobin (HbA1c; mmol/mol)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-diabetic medications (n)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-obesity medications (n)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in health-related quality of life scores (EuroQol-5D-5L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rehan Haidry, MD principal investigator
Cleveland Clinic London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes Mellitus, Type 2, run by Cleveland Clinic London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Norton, MD (+442034237500, cclendoscopyresearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body weight loss percentage (TBWL%) (time frame: 6-months, 1-, 2-, 3-, 5-years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.