title: Rationale and design of Short-Term EXenatide therapy in Acute ischaemic Stroke (STEXAS): a randomised, open-label, parallel-group study.
abstract: BACKGROUND
  Both hyperglycaemia and hypoglycaemia in acute ischaemic stroke (AIS) are associated with increased infarct size and worse functional outcomes. Thus, therapies that can maintain normoglycaemia during stroke are clinically important. Glucagon-like peptide 1 (GLP-1) analogues, including exenatide, are routinely used in the treatment of hyperglycaemia in type 2 diabetes, but data on the usefulness of this class of agents in the management of elevated glucose levels in AIS are limited. Owing to their glucose-dependent mechanism of action, GLP-1 analogues are associated with a low risk of hypoglycaemia, which may give them an advantage over intensive insulin therapy in the acute management of hyperglycaemia in this setting.
  
  
  METHODS
  The Short-Term EXenatide therapy in Acute ischaemic Stroke study is a randomised, open-label, parallel-group pilot study designed to investigate the efficacy of exenatide at lowering blood glucose levels in patients with hyperglycaemia with AIS. A total of 30 patients presenting with AIS and blood glucose levels >10 mmol/L will be randomised to receive the standard therapy (intravenous insulin) or intravenous exenatide for up to 72 h. Outcomes including blood glucose levels within the target range (5-10 mmol/L), the incidence of hypoglycaemia and the feasibility of administering intravenous exenatide in this patient population will be assessed. A follow-up visit at 3 months will facilitate evaluation of neurological outcomes post-stroke.
  
  
  BACKGROUND
  This study has been approved by the local Institutional Review Board (Northern Sydney Local Health District Human Research Ethics Committee). The study results will be communicated via presentations at scientific conferences and through publication in peer-reviewed journals.
  
  
  CONCLUSIONS
  As GLP-1 analogues require elevated glucose levels to exert their insulin potentiating activity, the use of exenatide in the management of hyperglycaemia in AIS may reduce the incidence of hypoglycaemia, thereby conferring a benefit in morbidity and mortality for patients in the long term.
  
  
  BACKGROUND
  ACTRN12614001189617.
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, Sydney, New South Wales, Australia University of Sydney, Northern Clinical School, Sydney, New South Wales, Australia Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
authors.forename: Rachel T
authors.initials: RT
authors.lastname: McGrath
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, Sydney, New South Wales, Australia University of Sydney, Northern Clinical School, Sydney, New South Wales, Australia.
authors.forename: Samantha L
authors.initials: SL
authors.lastname: Hocking
authors.affiliation: Department of Neurology, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Miriam
authors.initials: M
authors.lastname: Priglinger
authors.affiliation: Department of Neurology, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Day
authors.affiliation: University of Sydney, Northern Clinical School, Sydney, New South Wales, Australia Department of Neurology, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Geoffrey K
authors.initials: GK
authors.lastname: Herkes
authors.affiliation: University of Sydney, Northern Clinical School, Sydney, New South Wales, Australia Department of Neurology, Royal North Shore Hospital, Sydney, New South Wales, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Krause
authors.affiliation: Department of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, Sydney, New South Wales, Australia University of Sydney, Northern Clinical School, Sydney, New South Wales, Australia.
authors.forename: Gregory R
authors.initials: GR
authors.lastname: Fulcher
mesh_terms: D001786:Blood Glucose / Q000187:drug effects; D000077270:Exenatide; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000150:complications* / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin; D008297:Male; D010455:Peptides / Q000627:therapeutic use*; D010865:Pilot Projects; D012107:Research Design; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D014688:Venoms / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; D014688:Venoms; D000077270:Exenatide