EUCTR2012-004988-42-GB
Active, not recruiting
Not Applicable
REVISE-Diabesity: Randomisation to Endoluminal intestinal liner alone Versus with Incretin analogue in SustainEd Diabesity - REVISE-Diabesity
ConditionsCombined Type 2 diabetes mellitus and obesity.MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsVictoza
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Combined Type 2 diabetes mellitus and obesity.
- Sponsor
- Sandwell and West Birmingham Hospitals NHS Trust
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be eligible to be included in this randomised clinical trial if they meet the following inclusion criteria: 1\. participation in ABCD Nationwide Liraglutide Audit with data for at least 6 months, 2\. HbA1c \=7\.5% after at least 6 months’ Liraglutide treatment, 3\. BMI \=35 Kg/m2 (\=30 Kg/m2 for Asian origin patients), 4\. stable weight and HbA1c in preceding 3 months (\<3 Kg reduction in weight and \<0\.3% reduction in HbA1c).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 65
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 7
Exclusion Criteria
- •Exclusion criteria will include the following: abnormal intestinal anatomy; contraindication to oesophago\-gastroduoenoscopy; previous bariatric surgery or bowel surgery; active infection or CRP \>10; anticoagulation therapy; coagulopathy INR \>1\.3; eGFR \<30; known portal hypertension; previous pancreatitis or amylase \> 3 times the upper limit of normal; uncontrolled cardiovascular disease; lactating or pregnant females. 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 if randomised to that arm 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.
Outcomes
Primary Outcomes
Not specified
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