Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher Gray

ORCID ID

Contact details

Sunderland Royal Hospital
Department of Medicine for the Elderly
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)191 565 6256 ext 41245
chris.gray@chs.northy.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRCC37R R/1805/7005

Study information

Scientific title

The Glucose Insulin in Stroke Trial (GIST)

Acronym

GIST UK

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.

Ethics approval

Not provided at time of registration

Study design

Multi-centre randomised controlled trial with blinded outcome assessments

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

All-cause mortality at 12 weeks.

Secondary outcome measures

Proportion of patients with a poor outcome (modified Rankin score 4 - 6) at 12 weeks between treatment groups.

Overall trial start date

01/09/2002

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

2500

Participant 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

Recruitment start date

01/09/2002

Recruitment end date

01/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Gray CS, O'Connell JE, Stroke: beyond thrombolysis and back to basics., QJM, 2003, 96, 3, 179-181.

  2. Gray CS, Hildreth AJ, Alberti GK, O'Connell JE, , Poststroke hyperglycemia: natural history and immediate management., Stroke, 2004, 35, 1, 122-126, doi: 10.1161/01.STR.0000106916.81680.C0.

  3. Gray CS, Scott JF, French JM, Alberti KG, O'Connell JE, Prevalence and prediction of unrecognised diabetes mellitus and impaired glucose tolerance following acute stroke., Age Ageing, 2004, 33, 1, 71-77.

  4. Gray CS, Hildreth AJ, Sandercock PA, O'Connell JE, Johnston DE, Cartlidge NE, Bamford JM, James OF, Alberti KG, , Glucose-potassium-insulin infusions in the management of post-stroke hyperglycaemia: the UK Glucose Insulin in Stroke Trial (GIST-UK)., Lancet Neurol, 2007, 6, 5, 397-406, doi: 10.1016/S1474-4422(07)70080-7.

Additional files

Editorial Notes