Effects of Exenatide on sleepiness and driving performance
Research type
Research Study
Full title
Effects of Exenatide on excess daytime sleepiness (EDS), wakefulness and driving performance in obese type-2 diabetes patients without sleep apnea – proof of concept study
IRAS ID
13210
Contact name
Iskandar Idris
Sponsor organisation
Sherwood Forest Hospitals NHS Trust
Eudract number
2008-008141-37
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Excess daytime sleepiness (EDS) is a common complaint among overweight patients with diabetes. Whilst it was previously thought that EDS is due to a combination of poor blood sugar control and airway obstruction during sleep, the latter known as obstructive sleep apnoea (OSA), recent studies have now shown that being overweight per se is responsible for EDS, even in patients without OSA. This is thought to occur as a result of abnormal inflammatory hormones produced from excess amount of fat cells, collectively known as Ó?somnogenic adipocytokines?Â. These cytokines are also well known to impair body??s own insulin action and have a negative impact on blood sugar control. Since conventional treatment to improve blood sugar control often leads to weight gain, symptoms of EDS have traditionally been difficult to resolve. We therefore aim to establish if treatment with exenatide - a novel antidiabetic therapy that targets both blood sugar control and weight, will improve symptoms of EDS, wakefulness and driving performance among overweight patients with diabetes but without OSA. If EDS and driving performance improve, this will increase our understanding of factors that increase the risk of EDS, while also introducing another treatment option to not only improve patient??s quality of life but also safety to the public.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
09/H0408/70
Date of REC Opinion
14 Jul 2009
REC opinion
Further Information Favourable Opinion