Endobarrier in diabetes with obstructive sleep apneoa

Not Applicable

Completed

• Conditions: Specialty: Diabetes, Primary sub-specialty: Both; UKCRC code/ Disease: Metabolic/ Diabetes mellitus, Respiratory/ Other diseases of the respiratory system; Respiratory; Obstructive sleep apneoa

• Registration Number: ISRCTN33788132
• Lead Sponsor: Sandwell and West Birmingham Hospitals NHS Trust

Brief Summary

2020 Abstract results in https://pubmed.ncbi.nlm.nih.gov/32840677/ (added 10/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-22
• Study Completion: 2019-07-12
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement for continuous positive airway pressure (CPAP) treatment which will be assessed by sleep studies at screening visit and at months 3,6,9,12,15,18,21 and 24.CPAP(continuous positive airway pressure) treatment which will be assessed by sleep studies at screening visit and at months 3, 6, 9, 12, 15, 18, 21 and 24.