Investigating Diabetic Neuropathy in Intensive Glycaemic Control
Research type
Research Study
Full title
Investigating Diabetic Neuropathy in Intensive Glycaemic Control
IRAS ID
246881
Contact name
Uazman Alam
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Tight glycaemic control is a major clinical goal for patients with diabetes due to unequivocal evidence that it reduces incidence of microvascular complications. However, rapid substantial reduction in HbA1c can lead to diabetic retinopathy (DR) progression in the short term. This phenomenon is not benign and can be associated with substantial visual loss. The effects of rapid substantial reduction in HbA1c on other diabetic microvascular complications including neuropathy are not well described. This is a topical area as recent trials of novel hypoglycaemic agents such as GLP-1 agonists have demonstrated very rapid improvement in HbA1c. Recent case studies suggest that the novel non-invasive re-iterative modality, corneal confocal microscopy (CCM) can detect worsening of diabetic neuropathy prior to conventional measures of neuropathy and before the development of foot complications.
We hypothesise that, in a proportion of subjects, rapid substantial reduction in HbA1c leads to worsening of diabetic neurodegeneration. We believe this is manifest in the retina and cornea as well as the peripheral nervous system. The proposed study focuses on an observational, prospective cohort study of subjects with pre-existing pre-proliferative diabetic retinopathy (PPDR) attending the Royal Liverpool University Hospital diabetes clinics and St.Paul's Eye Unit for intensive lowering of HbA1c.
One-hundred and twenty four people with PPDR who will be having intensification of will have peripheral neurological assessment through clinical signs and symptoms, electrophysiology, CCM, ocular coherence tomography (OCT) and ocular coherence tomography angiography (OCTA) in relation to comprehensive neuropathy phenotyping and will be followed up at baseline, 3 months and 6 months.
REC name
North West - Preston Research Ethics Committee
REC reference
18/NW/0646
Date of REC Opinion
30 Oct 2018
REC opinion
Further Information Favourable Opinion