ISRCTN33788132已完成未知
In type 2 diabetes patients with obesity and obstructive sleep apnoea (OSA) who are on CPAP(continuous positive airway pressure) machine, will treatment with endobarrier lead to an improvement sleep apnoea that some no longer need treatment with overnight CPAP?
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
2020 Abstract results in https://pubmed.ncbi.nlm.nih.gov/32840677/ (added 10/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 08/02/2017:
- •1. Moderate OSA
- •2. On CPAP
- •3. Type 2 diabetes or prediabetes with HbA1c between 42 and 48 mmol/mol
- •4. Obesity BMI =30 and =45 Kg/m2
- •5. Aged 18 years and over
- •6. Capable of giving informed consent
- •Original inclusion criteria:
- •1. Moderate OSA
- •2. On CPAP
- •3. Type 2 diabetes
- •4. Obesity BMI =30 and =40 Kg/m2
- •5. Aged 18 years and over
- •6. Capable of giving informed consent
排除标准
- •1. Abnormal intestinal anatomy
- •2. Contraindication to oesophagogastroduoenoscopy
- •3. Previous bariatric surgery or bowel surgery
- •4. Active infection
- •5. Anticoagulation therapy
- •6. Coagulopathy INR >1.3
- •7. Estimated Glomerular Filtration Rate (eGFR) <30
- •8. Known portal hypertension
- •9. Uncontrolled cardiovascular disease
- •10. Lactating or pregnant females
- •11. Excess anaesthetic risk
- •12. Patients taking non steroidal antiinflammatory agents will need to discontinue these for the duration of Endobarrier implantation
- •13. Patients taking aspirin with active ischaemic heart disease or cerebrovascular disease or those in whom aspirin treatment should continue. Patients taking regular aspirin will need to discontinue it for the duration of the Endobarrier implantation and so for those in whom it is taken for primary prevention, the potential risks and benefits of deciding to discontinue aspirin will be weighed up by the clinician concerned in consultation with the patient.
研究者
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