The Glucose Insulin in Stroke Trial (GIST)

ISRCTN	ISRCTN31118803
DOI	https://doi.org/10.1186/ISRCTN31118803
Protocol serial number	RRCC37R R/1805/7005
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 01/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Christopher Gray
Scientific

Sunderland Royal Hospital
Department of Medicine for the Elderly
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Phone	+44 (0)191 565 6256 ext 41245
Email	chris.gray@chs.northy.nhs.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial with blinded outcome assessments
Secondary study design	Randomised controlled trial
Scientific title	The Glucose Insulin in Stroke Trial (GIST)
Study acronym	GIST UK
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Cerebrovascular disease
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	All-cause mortality at 12 weeks.
Key secondary outcome measure(s)	Proportion of patients with a poor outcome (modified Rankin score 4 - 6) at 12 weeks between treatment groups.
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	2500
Key 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.
Key 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
Date of first enrolment	01/09/2002
Date of final enrolment	01/02/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Sunderland Royal Hospital

Sunderland
SR4 7TP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Date created	Peer reviewed?	Patient-facing?
Results article	01/05/2007	Yes	No
Other publications	01/03/2003	Yes	No
Other publications	01/01/2004	Yes	No
Other publications	01/01/2004	Yes	No

Editorial Notes

01/09/2022: Internal review.