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The Glucose Insulin in Stroke Trial (GIST)
ISRCTN ISRCTN31118803
DOI 10.1186/ISRCTN31118803
ClinicalTrials.gov identifier
EudraCT number
Public title The Glucose Insulin in Stroke Trial (GIST)
Scientific title
Acronym GIST UK
Serial number at source RRCC37R R/1805/7005
Study hypothesis Objectives:
To determine by means of a multi-centre randomised controlled clinical trial whether outcome from acute stroke can be favourably influenced by glucose/potassium/insulin induced and maintained euglycaemia.
Lay summary
Ethics approval Not provided at time of registration
Study design Multi-centre randomised controlled trial with blinded outcome assessments
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular diseases: Cerebrovascular disease
Participants - inclusion criteria All acute stroke patients (less than 24 hours onset) with cerebral infarction (CI) or primary intracerebral haemorrhage (PICH) and admission plasma glucose greater than 6.1 and less than 17 mMol/l.
Participants - exclusion criteria 1. Subarachnoid haemorrhage
2. Renal failure (urea 320 mMol/l or creatinine 3200 mMol/l)
3. Anaemia (Hb less than 9.0 g/dl)
4. Coma
5. Isolated posterior circulation syndromes with no physical disability
6. Pure language disorders
7. Established history of insulin dependent diabetes mellitus
8. Previous disabling stroke (Modified Rankin score 3)
9. Established diagnosis of dementia or abbreviated mental test score less than 7/10
10. Symptomatic cardiac failure - New York Heart Association (NYHA) Grade 3 or 4
Anticipated start date 01/09/2002
Anticipated end date 30/06/2006
Status of trial Completed
Patient information material
Target number of participants 2500
Interventions 1. Treatment with intravenous 10% glucose solution, 20 mmol KCL and Actrapid insulin (initial insulin 16 units/500ml) at 100 ml per hour.
2. Control treatment with intravenous N saline at 100 ml per hour. Treatment is continued for 24 hours with the objective in the treatment group to maintain blood glucose between 4-7 mmol/L.

Results:
Target recruitment 2,500 patients to detect a minimum 6% difference in mortality at 5% level, power 80%.

Conclusion:
This is the first ever clinical trial of glucose/potassium/insulin induced and maintained euglycaemia following stroke the results of which will be available in late 2006.
Primary outcome measure(s) All cause mortality at 12 weeks.
Secondary outcome measure(s) Proportion of patients with a poor outcome (modified Rankin score 4 - 6) at 12 weeks between treatment groups.
Sources of funding NHS Executive Northern and Yorkshire (UK)
Trial website
Publications Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/12615981
2. http://www.ncbi.nlm.nih.gov/pubmed/14671236
3. http://www.ncbi.nlm.nih.gov/pubmed/14695867
4. http://www.ncbi.nlm.nih.gov/pubmed/17434094
Contact name Prof  Christopher  Gray
  Address Sunderland Royal Hospital
Department of Medicine for the Elderly
Kayll Road
  City/town Sunderland
  Zip/Postcode SR4 7TP
  Country United Kingdom
  Tel +44 (0)191 565 6256 ext 41245
  Fax +44 (0)191 569 9767
  Email chris.gray@chs.northy.nhs.uk
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0) 20 7307 2622
  Fax +44 (0) 20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 23/01/2004
Last edited 19/02/2008
Date ISRCTN assigned 23/01/2004
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