Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:53 PM
Study NCT ID:
NCT06376305
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EndoBarrier in Obstructive Sleep Apnoea Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Requirement for continuous positive airway pressure'}], 'secondaryOutcomes': [{'measure': 'Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Apnea-hypopnea index (AHI)'}, {'measure': 'Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Obstructive sleep apnoea (OSA) symptoms'}, {'measure': 'Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Continuous positive airway pressure (CPAP) pressures'}, {'measure': 'Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Glycated haemoglobin'}, {'measure': 'Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months', 'timeFrame': 'At baseline, and then at 12 and 24 months', 'description': 'Fasting plasma glucose'}, {'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', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Weight and Body mass index (BMI)'}, {'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', 'timeFrame': 'At screening, baseline, and then every 3 months, up to 24 months', 'description': 'Composite scores of NAFLD severity'}, {'measure': 'Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months', 'timeFrame': 'At baseline, and then at 3, 12 and 24 months', 'description': 'Circulating free testosterone, fasting insulin and C-Peptide'}, {'measure': 'Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Blood pressure'}, {'measure': 'Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months', 'timeFrame': 'Every 3 months, up to 24 months', 'description': 'Diabetes treatment'}, {'measure': 'Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months', 'timeFrame': 'At baseline and then at 6, 12 and 24 months', 'description': 'Quality of life score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EndoBarrier'], 'conditions': ['Type 2 Diabetes', 'Obstructive Sleep Apnoea', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '23526068', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '19858703', 'type': 'RESULT', '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: 10.1097/SLA.0b013e3181bdfbff.'}]}, 'descriptionModule': {'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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate OSA on CPAP fulfilling NICE criteria for CPAP(AHI between 15 and 29 with symptoms)\n* Prediabetes(HbA1c between 42 \\& 48 mmol/mol) or confirmed type 2 diabetes (HbA1C≥48mmol/mol)\n* Obesity BMI ≥30 and ≤45 Kg/m2\n* Age ≥ 18 years\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* Abnormal intestinal anatomy\n* Contraindication to oesophagogastroduoenoscopy\n* Previous bariatric surgery or bowel surgery\n* Active infection\n* Anticoagulation therapy\n* Coagulopathy INR \\>1.3\n* Estimated Glomerular Filtration Rate (eGFR)\\<30\n* Known portal hypertension\n* Uncontrolled cardiovascular disease\n* Lactating or pregnant females\n* Excess anaesthetic risk\n* Patients taking non-steroidal anti-inflammatory agents will need to discontinue these for the duration of Endobarrier implantation\n* Patients taking aspirin/clopidogrel with active ischaemic heart disease or cerebrovascular disease(secondary prevention)'}, 'identificationModule': {'nctId': 'NCT06376305', 'acronym': 'End-OSA', 'briefTitle': 'EndoBarrier in Obstructive Sleep Apnoea Study', 'organization': {'class': 'OTHER', 'fullName': 'Sandwell & West Birmingham Hospitals NHS Trust'}, 'officialTitle': 'EndoBarrier Obstructive Sleep Apnoea Study', 'orgStudyIdInfo': {'id': '176786'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EndoBarrier in diabetes with obstructive sleep apnoea', 'description': 'The arm will consist of patients diabetes or prediabetes who also have moderate obstructive sleep apnoea requiring continuous positive pressure ventilation', 'interventionNames': ['Device: EndoBarrier']}], 'interventions': [{'name': 'EndoBarrier', 'type': 'DEVICE', 'description': '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.\n\nAt 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.', 'armGroupLabels': ['EndoBarrier in diabetes with obstructive sleep apnoea']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B18 7QH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'City Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Bob Ryder', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association of British Clinical Diabetologists', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dr Bob Ryder', 'investigatorAffiliation': 'Sandwell & West Birmingham Hospitals NHS Trust'}}}}