Diabetic Neuropathies Clinical Trial
Official title:
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.
Rationale: Poorly controlled diabetes mellitus is associated with microvascular
complications, which includes peripheral neuropathy. Peripheral neuropathy associated with
diabetes is a painful condition. Its diagnosis is hampered by painful and long nerve
conduction studies which fail to diagnose small nerve neuropathy. It is important to study
methods of noninvasive methods of early detection, which are sensitive and specific in
diagnosing early neuropathy and we propose a novel study that this can be detected in the
cornea of the eye.
Aims:
- Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density,
nerve branch density, and fiber length) and compare the results to healthy controls
using corneal confocal microscopy (CCM).
- Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral
neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin
biopsies and nerve conduction studies
- Obtain much needed normative values for CCM in adolescents and intraepidermal nerve
fiber density from skin biopsies in subjects with type 1 diabetes.
- As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha,
and fibrinogen in patients with diabetes in those with neuropathy Vs. without
neuropathy.
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