Endobarrier in diabetes with obstructive sleep apneoa

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?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33788132

Enrollment

Registered

2016-06-22

Start date

2016-03-14

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Diabetes, Primary sub-specialty: Both

Interventions

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 endobarr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
1. Apnoea hyperapnia index (AHI) is measured by sleep studies at screening, 3, 6, 9, 12, 15, 18, 21 and 24 months 2. Obstructive sleep aponea (OSA) symptoms are measured by sleep studies at screening, 3, 6, 9, 12, 15, 18, 21 and 24 months 3. Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, 3, 6, 9, 12, 15, 18, 21 and 24 months 4. Glycated haemoglobinis measured by blood test (HbA1c) at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 5. Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, 12 and 24 months 6. Weight and Body mass index (BMI) is measured by checking weight as well as height at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 7. Composite scores of NAFLD severity derived from age, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), BMI, platelets and serum albumin are measured by blood tests (ALT, AST, platelets, albumin), age and observations (weight, height) at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 8. Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, 3, 12 and 24 months 9. Blood pressure is measured by checking blood pressure at sitting at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 10. Diabetes treatment including need for insulin is measured at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 11. Quality of life scores is measured by EQ-5D questionnaire at baseline and 6, 12 and 24 months 12. Sustainability of primary outcome and of the secondary outcomes during the year following explantation of Endobarrier is measured by blood tests, sleep studies and interview at 15, 18, 21 and 24 months Added 08/02/2017: 13. Circulating free testosterone, insulin and c-peptide level are measured using blood testing at baseline, 3, 12 and 24 months	—

Measure

Time frame

1. Apnoea hyperapnia index (AHI) is measured by sleep studies at screening, 3, 6, 9, 12, 15, 18, 21 and 24 months 2. Obstructive sleep aponea (OSA) symptoms are measured by sleep studies at screening, 3, 6, 9, 12, 15, 18, 21 and 24 months 3. Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, 3, 6, 9, 12, 15, 18, 21 and 24 months 4. Glycated haemoglobinis measured by blood test (HbA1c) at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 5. Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, 12 and 24 months 6. Weight and Body mass index (BMI) is measured by checking weight as well as height at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 7. Composite scores of NAFLD severity derived from age, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), BMI, platelets and serum albumin are measured by blood tests (ALT, AST, platelets, albumin), age and observations (weight, height) at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 8. Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, 3, 12 and 24 months 9. Blood pressure is measured by checking blood pressure at sitting at screening, baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 10. Diabetes treatment including need for insulin is measured at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months 11. Quality of life scores is measured by EQ-5D questionnaire at baseline and 6, 12 and 24 months 12. Sustainability of primary outcome and of the secondary outcomes during the year following explantation of Endobarrier is measured by blood tests, sleep studies and interview at 15, 18, 21 and 24 months Added 08/02/2017: 13. Circulating free testosterone, insulin and c-peptide level are measured using blood testing at baseline, 3, 12 and 24 months

—

Countries

England, United Kingdom

Contacts

Public ContactMahendra Yadagiri

mahender.yadagiri@doctors.org.uk+44 1215 074591

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026