Type 2 DiabetesEnd-OSANCT06376305
EndoBarrier in Obstructive Sleep Apnoea Study
A study testing EndoBarrier in people with Type 2 Diabetes and Obstructive Sleep Apnoea, run by Dr Bob Ryder at 1 site in United Kingdom.
Trial summary
Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obstructive Sleep Apnoea, Obesity
- What is being tested?
- EndoBarrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate OSA on CPAP fulfilling NICE criteria for CPAP(AHI between 15 and 29 with symptoms)
- Prediabetes(HbA1c between 42 \& 48 mmol/mol) or confirmed type 2 diabetes (HbA1C≥48mmol/mol)
- Obesity BMI ≥30 and ≤45 Kg/m2
- Age ≥ 18 years
- Capable of giving informed consent
Who cannot join
- Abnormal intestinal anatomy
- Contraindication to oesophagogastroduoenoscopy
- Previous bariatric surgery or bowel surgery
- Active infection
- Anticoagulation therapy
- Coagulopathy INR >1.3
Show all 13Show fewer
- Estimated Glomerular Filtration Rate (eGFR)<30
- Known portal hypertension
- Uncontrolled cardiovascular disease
- Lactating or pregnant females
- Excess anaesthetic risk
- Patients taking non-steroidal anti-inflammatory agents will need to discontinue these for the duration of Endobarrier implantation
- Patients taking aspirin/clopidogrel with active ischaemic heart disease or cerebrovascular disease(secondary prevention)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EndoBarrier Obstructive Sleep Apnoea Study
Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment.
Read the detailed description
Once the participant has decided to take part in the study, they will be invited for signing a consent form and screening checks which will include medical history, examination, blood tests (approximately 10 ml) and sleep studies (at home without CPAP) on two occasions within one week to determine whether they are eligible for the study. If they fulfil all the criteria and once recruited into the study, they will be assessed for placement of EndoBarrier by gastroenterologists (tummy doctors) followed by its insertion in City Hospital as a day case procedure. There may be individual or group information sessions including the use of models and videos to describe insertion and removal of EndoBarrier devices. Potential participants will be offered the opportunity to ask questions. There will be trial assessment visits for every 3 months until one year after the insertion of EndoBarrier and then for every 3 months up to one year following its removal. During these visits, participants are assessed clinically and have blood tests (approximately 10 ml taken in a fasted state), sleep studies and quality of life questionnaires. EndoBarrier will be removed after 1 year, again, as a day case procedure.
- Conditions
- Type 2 Diabetes, Obstructive Sleep Apnoea, Obesity
- Being tested
- EndoBarrier
- Keywords
- EndoBarrier
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrierDevice
During screening visit, a brief history, examination, blood tests and 2 sleep studies within a gap of 1 week will be performed. Then, there will be an assessment by gastroenterologist for EndoBarrier insertion. EndoBarrier will be inserted endoscopically as a day case procedure after the midnight fast, under general anaesthesia. Following the EndoBarrier insertion, there will be 3 monthly trial visits until one year where the following assessments will be performed - brief interview, observations, blood tests, urine test, dietitian review, compliance check with CPAP and quality of life questionnaire.
At the end of one year, EndoBarrier will be removed endoscopically again as a day case procedure under general anaesthesia. Then, there will be follow up trial visits every 3 months up to one year where there will be clinical assessments, sleep studies, blood tests, urine test, dietitian, compliance check and quality of life questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| EndoBarrier in diabetes with obstructive sleep apnoea | Other | The arm will consist of patients diabetes or prediabetes who also have moderate obstructive sleep apnoea requiring continuous positive pressure ventilation Receives: Device: EndoBarrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months
Requirement for continuous positive airway pressure
Measured: Every 3 months, up to 24 months
Secondary outcomes (11)
Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months
Apnea-hypopnea index (AHI)
Measured: Every 3 months, up to 24 months
Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months
Obstructive sleep apnoea (OSA) symptoms
Measured: Every 3 months, up to 24 months
Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months
Continuous positive airway pressure (CPAP) pressures
Measured: Every 3 months, up to 24 months
Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months
Glycated haemoglobin
Measured: Every 3 months, up to 24 months
Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months
Fasting plasma glucose
Measured: At baseline, and then at 12 and 24 months
Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months
Weight and Body mass index (BMI)
Measured: Every 3 months, up to 24 months
Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI
Composite scores of NAFLD severity
Measured: At screening, baseline, and then every 3 months, up to 24 months
Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months
Circulating free testosterone, fasting insulin and C-Peptide
Measured: At baseline, and then at 3, 12 and 24 months
Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months
Blood pressure
Measured: Every 3 months, up to 24 months
Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months
Diabetes treatment
Measured: Every 3 months, up to 24 months
Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months
Quality of life score
Measured: At baseline and then at 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Bob Ryder
- Sponsor type
- University, hospital or other
- Collaborators
- Association of British Clinical Diabetologists
- Responsible party
- Sponsor-investigator, Dr Bob Ryder, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376305
- Sponsor's protocol ID
- 176786
- Acronym
- End-OSA
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.
PubMed 23526068Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43. doi: 10.1097/SLA.0b013e3181bdfbff.
PubMed 19858703
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoBarrier Obstructive Sleep Apnoea Study
- ClinicalTrials.gov ID
- NCT06376305
- Acronym / sponsor ID
- End-OSA / 176786
- Conditions
- Type 2 Diabetes, Obstructive Sleep Apnoea, Obesity
- Keywords
- EndoBarrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dr Bob RyderUniversity, hospital or other
- Collaborators
- Association of British Clinical Diabetologists
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Apr 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.
Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment.
Detailed description
Once the participant has decided to take part in the study, they will be invited for signing a consent form and screening checks which will include medical history, examination, blood tests (approximately 10 ml) and sleep studies (at home without CPAP) on two occasions within one week to determine whether they are eligible for the study. If they fulfil all the criteria and once recruited into the study, they will be assessed for placement of EndoBarrier by gastroenterologists (tummy doctors) followed by its insertion in City Hospital as a day case procedure. There may be individual or group information sessions including the use of models and videos to describe insertion and removal of EndoBarrier devices. Potential participants will be offered the opportunity to ask questions. There will be trial assessment visits for every 3 months until one year after the insertion of EndoBarrier and then for every 3 months up to one year following its removal. During these visits, participants are assessed clinically and have blood tests (approximately 10 ml taken in a fasted state), sleep studies and quality of life questionnaires. EndoBarrier will be removed after 1 year, again, as a day case procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoBarrier in diabetes with obstructive sleep apnoea | Other | Device: EndoBarrierThe arm will consist of patients diabetes or prediabetes who also have moderate obstructive sleep apnoea requiring continuous positive pressure ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate OSA on CPAP fulfilling NICE criteria for CPAP(AHI between 15 and 29 with symptoms)
- Prediabetes(HbA1c between 42 \& 48 mmol/mol) or confirmed type 2 diabetes (HbA1C≥48mmol/mol)
- Obesity BMI ≥30 and ≤45 Kg/m2
- Age ≥ 18 years
- Capable of giving informed consent
Key exclusion criteria (13 listed)
- Abnormal intestinal anatomy
- Contraindication to oesophagogastroduoenoscopy
- Previous bariatric surgery or bowel surgery
- Active infection
- Anticoagulation therapy
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 |
|---|---|---|
| EndoBarrierDuring screening visit, a brief history, examination, blood tests and 2 sleep studies within a gap of 1 week will be performed. Then, there will be an assessment by gastroenterologist for EndoBarrier insertion. EndoBarrier will be inserted endoscopically as a day case procedure after the midnight fast, under general anaesthesia. Following the EndoBarrier insertion, there will be 3 monthly trial visits until one year where the following assessments will be performed - brief interview, observations, blood tests, urine test, dietitian review, compliance check with CPAP and quality of life questionnaire. At the end of one year, EndoBarrier will be removed endoscopically again as a day case procedure under general anaesthesia. Then, there will be follow up trial visits every 3 months up to one year where there will be clinical assessments, sleep studies, blood tests, urine test, dietitian, compliance check and quality of life questionnaires. | Device | EndoBarrier in diabetes with obstructive sleep apnoea |
Primary outcome
Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Requirement for continuous positive airway pressure
11 secondary outcomes
Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months
Time frame: At baseline, and then at 12 and 24 months
Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI
Time frame: At screening, baseline, and then every 3 months, up to 24 months
Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months
Time frame: At baseline, and then at 3, 12 and 24 months
Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months
Time frame: Every 3 months, up to 24 months
Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months
Time frame: Every 3 months, up to 24 months
Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months
Time frame: At baseline and then at 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Results publication: PubMed 23526068de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.
- Results publication: PubMed 19858703Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43. doi: 10.1097/SLA.0b013e3181bdfbff.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoBarrier in people with Type 2 Diabetes and Obstructive Sleep Apnoea, run by Dr Bob Ryder 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 19 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months (time frame: Every 3 months, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376305, which also lists 2 linked publications.
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 19 Apr 2024.