The role of gut hormones replacement in improving blood flow to the brain after stroke that affects swallowing.

The role of GLP-1 analogues in reducing reperfusion injury after acute stroke in patients with impaired swallowing. - Liraglutide after Acute Stroke Trial (LAST).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003572-36-GB

Enrollment

Registered

2011-12-06

Start date

2011-12-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We plan to give a synthetic form of GLP-1 (Liraglutide) that is already available and licensed for use in patients with diabetes in the UK, to patients who have had an acute stroke, in order to determine whether increased levels protect the brain during its recovery, resulting in better recovery. MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Liraglutide Product Name: Liraglutide Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over the age of 18 years, presenting within 6 hours of an acute stroke who are able to consent or have next of kins who can provide assent and are planned to be placed nil by mouth for at least 12 hours. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Inability to provide informed consent or inability to contact a relative or carer who can provide assent. Stroke as a result of an intra-cerebral bleed. Pregnancy and breast feeding. Liver impairment, Type I diabetes, Patients who are on insulin, Sulphonylurea therapy or other GLP-1 treatment, Hypersensitivity to Liraglutide Other contraindication for the use of Liraglutide (as per SmPC).

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a pilot study to inform and guide the processes needed for a larger multicentre trial, to estimate the cost and to prepare for an HTA/NIHR grant application. GLP-1 (Glucagon like peptide) is a gut hormone that is known to regulate blood flow in vessels and prevents cell-death. After a stroke, patients are often placed "Nil by Mouth" due to concerns over swallowing safely. This will reduce the levels of GLP-1. We wish to replace this GLP-1 using the preparation widely used for the treatment of Diabetes to determine if this benefits the blood supply to the brain and preservation of healthy brain. This pilot study will guide the processes required to organise the definitive study to determine the benefit of liraglutide after a stroke on clinical outcomes. Study Objectives: 1-To recruit 40 consecutive stroke patients presenting within 6 hours who are put nil by mouth. 2-To record basic data on patients who were eligible for recruitment but were not recruited..;Secondary Objective: Our secondary objective: 1- To record MRI volumetric infarction size after 1 week of treatment with liraglutide in addition to usual care vs. 1 week of standard care only. 2- To assess the benefit to clinical outcome after a stroke using the NIHSS scoring system (at 1 week and a 1 month) after 7 days of treatment with liraglutide, compared to usual care only. 3- To explore the effects of liraglutide treatment on systemic microvascular function and vascular autoregulation after an acute stroke and its impact on recovery from stroke. To assess the feasibilty of performing those microvascular assessments in a large multi centre trial.;Primary end point(s): To pilot the processes required to organise a definitive study to determine the benefit of liraglutide after a stroke on clinical outcomes. As part of this aim we will assess the feasibility of the study, for example, rate of participant recruitment, cost of running the study and the practicalities of performing the mic	—

Measure

Time frame

Main Objective: This is a pilot study to inform and guide the processes needed for a larger multicentre trial, to estimate the cost and to prepare for an HTA/NIHR grant application. GLP-1 (Glucagon like peptide) is a gut hormone that is known to regulate blood flow in vessels and prevents cell-death. After a stroke, patients are often placed "Nil by Mouth" due to concerns over swallowing safely. This will reduce the levels of GLP-1. We wish to replace this GLP-1 using the preparation widely used for the treatment of Diabetes to determine if this benefits the blood supply to the brain and preservation of healthy brain. This pilot study will guide the processes required to organise the definitive study to determine the benefit of liraglutide after a stroke on clinical outcomes. Study Objectives: 1-To recruit 40 consecutive stroke patients presenting within 6 hours who are put nil by mouth. 2-To record basic data on patients who were eligible for recruitment but were not recruited..;Secondary Objective: Our secondary objective: 1- To record MRI volumetric infarction size after 1 week of treatment with liraglutide in addition to usual care vs. 1 week of standard care only. 2- To assess the benefit to clinical outcome after a stroke using the NIHSS scoring system (at 1 week and a 1 month) after 7 days of treatment with liraglutide, compared to usual care only. 3- To explore the effects of liraglutide treatment on systemic microvascular function and vascular autoregulation after an acute stroke and its impact on recovery from stroke. To assess the feasibilty of performing those microvascular assessments in a large multi centre trial.;Primary end point(s): To pilot the processes required to organise a definitive study to determine the benefit of liraglutide after a stroke on clinical outcomes. As part of this aim we will assess the feasibility of the study, for example, rate of participant recruitment, cost of running the study and the practicalities of performing the mic

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Secondary

Measure	Time frame
Secondary end point(s): i) To compare the brain infarction size using MRI volumetric measurements after 1 week of treatment with Liraglutide in addition to usual care vs. 1 week of standard care only. ii) To assess the benefit to clinical outcome after a stroke using the NIHSS scoring system (at 1 week and 1 month) after 7 days of treatment with Liraglutide, compared to usual care only. iii) To assess the effect of Liraglutide treatment on microvascular function to determine whether improvement in microvascular function have detrimental effect on clinical outcome.;Timepoint(s) of evaluation of this end point: It is anticipated this study will recruit on average only one patient every 2 weeks. It is estimated therefore that the first interim analysis (12 patients) will take place after six months.	—

Measure

Time frame

Secondary end point(s): i) To compare the brain infarction size using MRI volumetric measurements after 1 week of treatment with Liraglutide in addition to usual care vs. 1 week of standard care only. ii) To assess the benefit to clinical outcome after a stroke using the NIHSS scoring system (at 1 week and 1 month) after 7 days of treatment with Liraglutide, compared to usual care only. iii) To assess the effect of Liraglutide treatment on microvascular function to determine whether improvement in microvascular function have detrimental effect on clinical outcome.;Timepoint(s) of evaluation of this end point: It is anticipated this study will recruit on average only one patient every 2 weeks. It is estimated therefore that the first interim analysis (12 patients) will take place after six months.

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Countries

United Kingdom

Contacts

Public ContactDavid Strain

Diabetes & Vascular Research Centre

david.strain@pms.ac.uk01392403017

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026