Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000983202
Ethics application status
Approved
Date submitted
16/09/2009
Date registered
13/11/2009
Date last updated
13/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Exenatide in acute ischemic stroke - effect on cerebral inflammation and glucose homeostasis
Scientific title
Exenatide in acute ischemic stroke - effect on cerebral inflammation and glucose homeostasis
Universal Trial Number (UTN)
U1111-1112-4778
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ischemic stroke 243852 0
Condition category
Condition code
Stroke 240028 240028 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241294 0
Treatment: Drugs
Comparator / control treatment
Historical control of stroke patients and normal volunteers will be used for comparison of inflammatory marker levels
Control group
Historical

Outcomes
Primary outcome [1] 240930 0
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.
Timepoint [1] 240930 0
at baseline and at 1,3,5,7 and 14 days
Secondary outcome [1] 257648 0
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.
Timepoint [1] 257648 0
Twice every day during hospital admission
Secondary outcome [2] 257649 0
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.
Timepoint [2] 257649 0
During hospital admission

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study is a non-randomized initial pilot study of 10 patients with acute ischemic stroke. All patients will receive Exenatide injection. The inflammatory marker levels in these 10 patients will be compared with levels obtained from historical controls.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2215 0
3128

Funding & Sponsors
Funding source category [1] 243748 0
University
Name [1] 243748 0
Monash university eastern clinical research unit
Country [1] 243748 0
Australia
Primary sponsor type
University
Name
Monash university eastern clinical research unit
Address
Level 3, Clive ward building
16 Arnold street, Box Hill
Vic 3128, Australia
Country
Australia
Secondary sponsor category [1] 237107 0
None
Name [1] 237107 0
Address [1] 237107 0
Country [1] 237107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243879 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 243879 0
5 Arnold Street, Box Hill, Victoria, 3128
Ph: 03-98953259
Ethics committee country [1] 243879 0
Australia
Date submitted for ethics approval [1] 243879 0
21/09/2009
Approval date [1] 243879 0
06/11/2009
Ethics approval number [1] 243879 0
E28/0910

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30293 0
Address 30293 0
Country 30293 0
Phone 30293 0
Fax 30293 0
Email 30293 0
Contact person for public queries
Name 13540 0
Christopher Bladin
Address 13540 0
Level 4, Clive ward building
16 Arnold street
Box Hill, Vic, 3128
Country 13540 0
Australia
Phone 13540 0
+61 3 98954974
Fax 13540 0
+61 3 98950304
Email 13540 0
chris.bladin@easternhealth.org.au
Contact person for scientific queries
Name 4468 0
Christopher Bladin
Address 4468 0
Level 4, Clive ward building
16 Arnold street
Box Hill, Vic, 3128
Country 4468 0
Australia
Phone 4468 0
+61 3 98954974
Fax 4468 0
+61 3 98950304
Email 4468 0
chris.bladin@easternhealth.org.au

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

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