Exenatide in acute ischemic stroke - effect on cerebral inflammation and glucose homeostasis

Phase 2

• Conditions: Acute ischemic stroke; Stroke - Ischaemic

• Registration Number: ACTRN12609000983202
• Lead Sponsor: Monash university eastern clinical research unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the levels of inflammatory/endothelial cell markes in acute ischemic stroke patients treated with Exenatide. C-Reactive Protein (CRP), Interleukin (IL)-6, IL-10, IL-18, Tumor Necrosis Factor (TMF) alpha, Matrix Metalloproteinase (MMP) 9, Plasminogen Activator Inhibitor (PAI) - 1 and adhesion molecules (ICAM-1, VCAM-1) will be assayed using ELISA technique from plasma.[at baseline and at 1,3,5,7 and 14 days]

Secondary Outcome Measures

Name	Time	Method
Glycemic control in patients with acute ischemic stroke receiving Exenatide. This will be done by measuring blood glucose levels at baseline and twice daily. Blood glucose level will be assessed by finger prick technique using a calibrated glucometer.[Twice every day during hospital admission];Incidence of side effects, especially hypoglycemia, nause or vomiting. Hypoglycemia will be diagnosed by twice daily blood glucose estimations. Any symptoms which could be potentially related to hypoglycemia will be investigated by immediate blood glucose estimation in addition to the twice daily tests. Nausea and vomiting will be assessed as mild, moderate or severe according to the level of patient distress by clinical judgement.[During hospital admission]