An interventional study of EndoBarrier in Type 2 Diabetes, Obstructive Sleep Apnoea and Obesity, sponsored by Dr Bob Ryder. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Dr Bob Ryder · Not applicable, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →This is the only study on the registry with Dr Bob Ryder as lead sponsor.
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Exclusion Criteria:
The arm will consist of patients diabetes or prediabetes who also have moderate obstructive sleep apnoea requiring continuous positive pressure ventilation
Device: EndoBarrier
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.
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
Time frame: Every 3 months, up to 24 months
Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months
Apnea-hypopnea index (AHI)
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
Obstructive sleep apnoea (OSA) symptoms
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
Continuous positive airway pressure (CPAP) pressures
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
Glycated haemoglobin
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
Fasting plasma glucose
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
Weight and Body mass index (BMI)
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
Composite scores of NAFLD severity
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
Circulating free testosterone, fasting insulin and C-Peptide
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
Blood pressure
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
Diabetes treatment
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
Quality of life score
Time frame: At baseline and then at 6, 12 and 24 months
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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