None listed
Conditions
Brief summary
Exenatide which is a drug approved for use in Type 2 Diabetes has been shown in animal experimental models of stroke to have neuroprotective effect. Elevated blood glucose level during stroke has been shown to be a cause of bad outcome and this can be seen even in non-diabetic patients as a stress response to stroke. . Exenatide, when administered to stroke patients may control blood glucose levels effectively and reduce insulin resistance, which may help in reducing cerebral inflammation after stroke. On this background we have designed this initial pilot study of Exenatide use in 10 patients with acute ischemic stroke to see the changes in inflammatory level markers and also to look at the safety and feasibility issues before a larger randomized controlled trial can be conducted.
Interventions
Role of Exenatide injection in acute ischemic stroke. Exenatide injection will be administered in dose of 5 mcg twice daily subcutaneously to selected acute stroke patients within 12 hours of symptom onset. The drug will administered for the duration of in-hospital admission with a minimum period of 5 days and maximum period of 2 weeks.
Sponsors
Monash university eastern clinical research unit
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
18 – 85 years Stroke symptom onset within 12 hours Measurable neurological deficit (National Institute of Health Stroke Scale [NIHSS] 4-22) Blood sugar level on admission = 3mmol/L Pre-morbid Modified Rankin Scale 0-2 Computed Tomography (CT) Scan Brain excluded intracerebral haemorrhage
Exclusion criteria
Unlikely to survive beyond 14 days Pregnant (known or suspected) or breast feeding Previous clinical stroke in the last one month Concomitant inflammatory disease Diabetic patients already on Exenatide or combination insulin and oral hypoglycaemic agents Have a known allergy or hypersensitivity to exenatide. Past history of pancreatitis or evidence of active pancreatitis. Patients with other severe gastrointestinal disease like gastroparesis and dumping syndrome Patients with end stage renal disease (creatinine clearance < 30 ml/mt)
Outcome results
None listed