A longitudinal study of sensory biomarkers of progression in patients with diabetic peripheral neuropathy using skin biopsies

Dyck, 1993, The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study, Neurology, 43, 817, 10.1212/WNL.43.4.817 Harris, 1993, Symptoms of sensory neuropathy in adults with NIDDM in the U.S. population, Diabetes Care, 16, 1446, 10.2337/diacare.16.11.1446 1993, The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus, N Engl J Med, 329, 977, 10.1056/NEJM199309303291401 1998, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet, 352, 837, 10.1016/S0140-6736(98)07019-6 1995, The Diabetes Control and Complications Trial Research Group. Effect of intensive diabetes treatment on nerve conduction in the Diabetes Control and Complications Trial, Ann Neurol, 38, 869, 10.1002/ana.410380607 Apfel, 1998, Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy. NGF Study Group, Neurology, 51, 695, 10.1212/WNL.51.3.695 Apfel, 2000, Efficacy and safety of recombinant human nerve growth factor in patients with diabetic polyneuropathy: a randomized controlled trial. rhNGF Clinical Investigator Group, JAMA, 284, 2215, 10.1001/jama.284.17.2215 Wellmer, 2001, A double-blind placebo-controlled clinical trial of recombinant human brain-derived neurotrophic factor (rhBDNF) in diabetic polyneuropathy, J Peripher Nerv Syst, 6, 204, 10.1046/j.1529-8027.2001.01019.x Anand, 2004, Neurotrophic factors and their receptors in human sensory neuropathies, Prog Brain Res, 146, 477, 10.1016/S0079-6123(03)46030-5 Apfel, 1994, Nerve growth factor administration protects against experimental diabetic sensory neuropathy, Brain Res, 634, 7, 10.1016/0006-8993(94)90252-6 Snider, 1994, Functions of the neurotrophins during nervous system development: what the knockouts are teaching us, Cell, 77, 627, 10.1016/0092-8674(94)90048-5 Dyck, 2007, Challenges in design of multicenter trials: end points assessed longitudinally for change and monotonicity, Diabetes Care, 30, 2619, 10.2337/dc06-2479 Tesfaye, 2007, Factors that impact symptomatic diabetic peripheral neuropathy in placebo-administered patients from two 1-year clinical trials, Diabetes Care, 30, 2626, 10.2337/dc07-0608 Sumner, 2003, The spectrum of neuropathy in diabetes and impaired glucose tolerance, Neurology, 60, 108, 10.1212/WNL.60.1.108 Singleton, 2001, Increased prevalence of impaired glucose tolerance in patients with painful sensory neuropathy, Diabetes Care, 24, 1448, 10.2337/diacare.24.8.1448 Novella, 2001, The frequency of undiagnosed diabetes and impaired glucose tolerance in patients with idiopathic sensory neuropathy, Muscle Nerve, 24, 1229, 10.1002/mus.1137 Smith, 2006, Lifestyle intervention for pre-diabetic neuropathy, Diabetes Care, 29, 1294, 10.2337/dc06-0224 Anand, 1996, The role of endogenous nerve growth factor in human diabetic neuropathy, Nat Med, 2, 703, 10.1038/nm0696-703 P.J. Dyck, Severity and staging of polyneuropathy. In: Gries FA, Cameron NE, Low PA, et al., editors. Text book of diabetic neuropathy. New York: Thieme; 2003. p. 170–74. Bril, 1999, NIS-LL: the primary measurement scale for clinical trial endpoints in diabetic peripheral neuropathy, Eur Neurol, 41, 8, 10.1159/000052074 Melzack, 1987, The short-form McGill Pain Questionnaire, Pain, 30, 191, 10.1016/0304-3959(87)91074-8 Atherton, 2007, Use of the novel Contact Heat Evoked Potential Stimulator (CHEPS) for the assessment of small fibre neuropathy: correlations with skin flare responses and intra-epidermal nerve fibre counts, BMC Neurol, 7, 21, 10.1186/1471-2377-7-21 Coppini, 2001, The natural history of diabetic peripheral neuropathy determined by a 12year prospective study using vibration perception thresholds, J Clin Neurosci, 8, 520, 10.1054/jocn.2001.0893 Krishnan, 2004, The LDIflare: a novel test of C-fiber function demonstrates early neuropathy in type 2 diabetes, Diabetes Care, 27, 2930, 10.2337/diacare.27.12.2930 Rage, 2010, The time course of CO2 laser-evoked responses and of skin nerve fibre markers after topical capsaicin in human volunteers, Clin Neurophysiol, 121, 1256, 10.1016/j.clinph.2010.02.159 Facer, 2000, Do nerve growth factor-related mechanisms contribute to loss of cutaneous nociception in leprosy?, Pain, 85, 231, 10.1016/S0304-3959(99)00273-0 Facer, 1998, Correlation of quantitative tests of nerve and target organ dysfunction with skin immunohistology in leprosy, Brain, 121, 2239, 10.1093/brain/121.12.2239 Gopinath, 2005, Increased capsaicin receptor TRPV1 in skin nerve fibres and related vanilloid receptors TRPV3 and TRPV4 in keratinocytes in human breast pain, BMC Womens Health, 5, 2, 10.1186/1472-6874-5-2 Smith, 2001, Epidermal nerve innervation in impaired glucose tolerance and diabetes-associated neuropathy, Neurology, 57, 1701, 10.1212/WNL.57.9.1701 Kennedy, 1996, Quantitation of epidermal nerves in diabetic neuropathy, Neurology, 47, 1042, 10.1212/WNL.47.4.1042 Facer, 2007, Differential expression of the capsaicin receptor TRPV1 and related novel receptors TRPV3, TRPV4 and TRPM8 in normal human tissues and changes in traumatic and diabetic neuropathy, BMC Neurol, 7, 11, 10.1186/1471-2377-7-11 Polydefkis, 2004, The time course of epidermal nerve fibre regeneration: studies in normal controls and in people with diabetes, with and without neuropathy, Brain, 127, 1606, 10.1093/brain/awh175 Shun, 2004, Skin denervation in type 2 diabetes: correlations with diabetic duration and functional impairments, Brain, 127, 1593, 10.1093/brain/awh180