nctId: NCT06376305 id: 176786 briefTitle: EndoBarrier in Obstructive Sleep Apnoea Study acronym: End-OSA overallStatus: COMPLETED date: 2016-03 date: 2019-12 date: 2019-12 date: 2024-04-19 date: 2024-04-19 name: Dr Bob Ryder class: OTHER name: Association of British Clinical Diabetologists briefSummary: 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. conditions: Type 2 Diabetes conditions: Obstructive Sleep Apnoea conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ACTUAL name: EndoBarrier 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 measure: Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months measure: Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months measure: Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months measure: Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months measure: Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months measure: 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 measure: 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 measure: Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months measure: Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months measure: Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months measure: Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City Hospital city: Birmingham zip: B18 7QH country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False