Observational Study of Small Fibre Neural Assessment in Diabetes V1.0
Research type
Research Study
Full title
An observational study of small fibre neural assessment in people with diabetes with or without the use of GLP-1ra analogue treatment
IRAS ID
178929
Contact name
Gerry Rayman
Contact email
Sponsor organisation
R&D Ipswich Hospital NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Title: An observational study of small fibre neural assessment in people with diabetes with or without the use of GLP-1ra analogue treatment
There is currently a lack of knowledge comparing the effect of various diabetes treatment therapies on small nerve fibre damage (neuropathy). This includes Liraglutide, a type of GLP-1 medication given to some Type 2 diabetes patients.
The aim of this study is to see if there is any change in small nerve fibre structure and function over a 6 month period in patients with Type 2 diabetes on different treatments, in particular Liraglutide, a GLP1-ra. To do this, 3 groups will be looked at:
1) Healthy Volunteers (control group) - 16 participants who are not diagnosed with Type 2 Diabetes and do not have known clinical neuropathy.
2) Type 2 Diabetes Group – 16 participants who have previously been diagnosed with Type 2 diabetes. This group may be on a variety of Type 2 diabetes therapy treatments other than Liraglutide.
3) Type 2 Diabetes Group about to commence Liraglutide - 16 participants who have Type 2 diabetes and are about to start taking Liraglutide as part of their normal course of treatment.
Recruitment and assessment methods (at baseline and 6months) will take place at the Ipswich Hospital Diabetes Centre and will include: blood tests, confocal microscopy, modified LDIflare, neuropathy disability score, quantitative sensory testing, sural nerve conduction velocity and amplitude, and a quality of life questionnaire. The novelty of this research is that such assessments might be able to tell us further the individual effects of diabetes therapies on neural function and structure in Type 2 diabetes patients.Funding for the study will be supported by the Diabetes Research Unit at Ipswich Hospital. The sponsors have agreed to register this study on clinicaltrials.gov once approval for the study has been given.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0102
Date of REC Opinion
10 May 2016
REC opinion
Further Information Favourable Opinion