Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
Diabetes Mellitus, Peripheral Neuropathies
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetic Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria: 18 years of age or above Have a diagnosis of Diabetes mellitus for at least a year Agree not to smoke whilst resident in the CRC Able to understand the patient information sheet and provide written informed consent Score above 12 on the LANSS Have neuropathic pain of diabetic origin Score above 25 on MMSE Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to 5 half-lives and will be of a relevant duration given the particular medication used. Exclusion Criteria: There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid) There is evidence of a recent ischaemic event There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night) Currently receiving treatment for malignancy Suffer from seizures including epilepsy There is evidence of a history of dependence on or abuse of alcohol/recreational drugs Need to use a wheel chair (incompatible with studies in a sleep laboratory) Involved in a clinical trial in last 3 months Pregnant, lactating or inadequate contraception Vision inadequate for the performance tests (as assessed at screening) Colour Blind Will not co-operate with study procedures Will not give permission to inform GP
Sites / Locations
- Royal Bournemouth Hospital
- Poole General Hospital
- University of Surrey Clinical Research Centre