SELESTIAL: Trial of Insulin to Control Blood Sugar After Acute Stroke Using Magnetic Resonance Imaging (MRI) End-Points

NCT00124826 | Completed Phase 2

• 4 other identifiers: 04/S0702/58Grant No: TSA 06/03MREC Ref: 04/MRE00/31R&D Ref: R030295
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

High blood sugar (hyperglycaemia) affects 40% of acute stroke patients and has a major adverse effect on survival and recovery. Increased production of lactic acid in brain tissue that has a poor blood supply is postulated to be the mechanism by which high blood sugar may worsen brain injury after stroke. Treatment with insulin infusions is proposed as a neuroprotective strategy, and a clinical trial is ongoing to test this hypothesis. However, the biological basis for insulin treatment has not been established, and there is uncertainty about the duration of insulin infusion that may be required to limit damage. Magnetic resonance spectroscopy (MRS) is a brain scanning technique that allows measurement of brain lactic acid. When performed in conjunction with conventional MRI scanning, the relationship of lactate accumulation to stroke expansion can be established. SELESTIAL is a randomised, placebo-controlled trial of insulin infusions of 24 or 72 hours (h) duration in acute stroke patients with hyperglycaemia, to establish whether insulin prevents lactate accumulation over the initial 72h after stroke, how this relates to stroke evolution, and the effect of treatment on stroke size and clinical outcomes at 1 week.

Conditions

Acute Stroke; Hyperglycemia

Keywords

stroke; cerebrovascular disease; hyperglycemia; magnetic resonance imaging; acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Lesion volume expansion at 1 week

Secondary Outcomes (5)

• Brain lactate concentration change baseline-day 3

• Change in National Institutes of Health Stroke Scale (NIHSS) baseline - day 7

• 30 day modified Rankin Scale score

• 30 day NIHSS

• 30 day Barthel Index

Interventions

Insulin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute stroke within 24h of onset
• Lesion on acute diffusion weighted MRI
• \>18 years age

You may not qualify if:

• Coma
• Major concomitant illness limiting survival

Sponsors & Collaborators

• University of Glasgow: lead
• South Glasgow University Hospitals NHS Trust: collaborator
• The Stroke Association, United Kingdom: collaborator

Study Sites (1)

Institute of Neurological Sciences

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Hyperglycemia; Cerebrovascular Disorders; Ischemic Stroke

Interventions

Insulin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Keith Muir, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2005
• First Posted: July 28, 2005
• Study Start: May 1, 2004
• Last Updated: February 1, 2006

Record last verified: 2005-07

Locations

GB (1)