Obesity Clinical Trial
— End-OSAOfficial title:
EndoBarrier Obstructive Sleep Apnoea Study
NCT number | NCT06376305 |
Other study ID # | 176786 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 2019 |
Verified date | April 2024 |
Source | Sandwell & West Birmingham Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Abnormal intestinal anatomy - Contraindication to oesophagogastroduoenoscopy - Previous bariatric surgery or bowel surgery - Active infection - Anticoagulation therapy - Coagulopathy INR >1.3 - 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | City Hospital | Birmingham |
Lead Sponsor | Collaborator |
---|---|
Dr Bob Ryder | Association of British Clinical Diabetologists |
United Kingdom,
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. — View Citation
Schouten 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: 1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Every 3 months, up to 24 months | |
Secondary | Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months | Apnea-hypopnea index (AHI) | Every 3 months, up to 24 months | |
Secondary | 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 | Every 3 months, up to 24 months | |
Secondary | 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 | Every 3 months, up to 24 months | |
Secondary | Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months | Glycated haemoglobin | Every 3 months, up to 24 months | |
Secondary | Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months | Fasting plasma glucose | At baseline, and then at 12 and 24 months | |
Secondary | 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) | Every 3 months, up to 24 months | |
Secondary | 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 | At screening, baseline, and then every 3 months, up to 24 months | |
Secondary | 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 | At baseline, and then at 3, 12 and 24 months | |
Secondary | Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months | Blood pressure | Every 3 months, up to 24 months | |
Secondary | Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months | Diabetes treatment | Every 3 months, up to 24 months | |
Secondary | Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months | Quality of life score | At baseline and then at 6, 12 and 24 months |
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