IIH Pressure
Research type
Research Study
Full title
The acute and chronic effects of gut neuropeptides on intracranial pressure regulation
IRAS ID
199418
Contact name
James Mitchell
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Idiopathic intracranial hypertension (IIH) is a condition of unknown cause. The condition is characterized by raised pressure in the brain and can cause disabling daily headaches and loss of sight, which can be permanent. The raised brain pressure squashes the nerves supplying the eye (also known as papilloedema) and this can affect vision and cause blindness. Over 90% of patients with IIH are overweight and weight loss is the most effective treatment. Other treatments for IIH have very little current evidence to support their use and few treatments in general are available for raised brain pressure which also occurs in hydrocephalus and traumatic brain injury.
Gut neuro-peptides are a group of hormones released by the gut with specific actions in the central nervous system. GLP-1 is a hormone that has known actions in the kidney to reduce blood pressure. Preliminary work has shown this mechanism to be similar to that regulating fluid secretion in the brain. Further preliminary work has shown that GLP-1 reduces intra-cranial pressure in animal models. GLP-1 drugs are currently used to treat diabetes and aid weight loss.
We propose to investigate the effects of the GLP-1 drug, Exenatide, on intra-cranial pressure in a prospective, randomized, placebo-controlled clinical trial.16 participants with active IIH will be recruited from neuro-ophthalmology clinics and will have telemetric intra-cranial pressure sensors fitted. They will be randomised to 2 groups receiving Exenatide or placebo and intra-cranial pressure will be recorded acutely and over 3 months. A second part of the trial will investigate the effect on intra-cranial pressure of 5 drugs commonly used to treat IIH.
The study will also provide valuable information regarding normal intra-cranial pressure variation as well as in response to the study drugs. The study will be run by the University of Birmingham and University Hospitals Birmingham NHS Trust.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0179
Date of REC Opinion
29 Jun 2017
REC opinion
Further Information Favourable Opinion