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Effect of early multifactorial therapy compared with routine care on microvascular outcomes at 5 years in people with screen-detected diabetes: a randomized controlled trial: the ADDITION-Europe Study.
Sandbæk, A, Griffin, SJ, Sharp, SJ, Simmons, RK, Borch-Johnsen, K, Rutten, GE, van den Donk, M, Wareham, NJ, Lauritzen, T, Davies, MJ, et al
Diabetes care. 2014;(7):2015-23
Abstract
OBJECTIVE To determine the benefit of multifactorial treatment on microvascular complications among people with type 2 diabetes detected by screening. RESEARCH DESIGN AND METHODS This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level. In four centers in Denmark; Cambridge, U.K.; the Netherlands; and Leicester, U.K., 343 general practices participated in the trial. Eligible for follow-up were 2,861 of the 3,057 people with diabetes detected by screening included in the original trial. Biomedical data on nephropathy were collected in 2,710 (94.7%) participants, retinal photos in 2,190 (76.6%), and questionnaire data on peripheral neuropathy in 2,312 (80.9%). The prespecified microvascular end points were analyzed by intention to treat. Results from the four centers were pooled using fixed-effects meta-analysis. RESULTS Five years after diagnosis, any kind of albuminuria was present in 22.7% of participants in the intensive treatment (IT) group and in 24.4% in the routine care (RC) group (odds ratio 0.87 [95% CI 0.72-1.07]). Retinopathy was present in 10.2% of the IT group and 12.1% of the RC group (0.84 [0.64-1.10]), and severe retinopathy was present in one patient in the IT group and seven in the RC group. Neuropathy was present in 4.9% and 5.9% (0.95 [0.68-1.34]), respectively. Estimated glomerular filtration rate increased between baseline and follow-up in both groups (4.31 and 6.44 mL/min, respectively). CONCLUSIONS Compared with RC, an intervention to promote target-driven, intensive management of patients with type 2 diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at 5 years.
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[Clinical improvement of diabetic neuropathy with carbamazepine or diclofenac treatment].
Tinoco-Samos, A, Córdova-Pérez, N, Arenas-Téllez, JM, Vargas-Girón, A, Zárate, A, Hernández-Valencia, M
Revista medica del Instituto Mexicano del Seguro Social. 2013;(5):496-501
Abstract
BACKGROUND diabetic neuropathy (DN) affects diverse aspects of a patient's life and there is not an optimal treatment. We did a comparative study of clinical improvement of DN with carbamazepine versus diclofenac. METHODS a prospective and longitudinal study of two groups with signs and symptoms of DN was done. One group had 30 patients who used carbamazepine with an initial dose of 200 mg, every 24 hours for one week, with a gradual increase of up to 200 mg every 6 hours for 10 months. The other group had 29 patients who used diclofenac sodium 100 mg every 12 hours. Bimonthly evaluations were made to graduate the pain according to the patients' perception and laboratory studies that included glucose and lipids profile. The statistical test used was ANOVA. RESULTS the patients who used carbamazepine presented absence of pain after 10 months compared with the diclofenac group (p < 0.01). The presence of cramps, muscular strength, pulses, perception of temperature and pressure improved significantly (p < 0.05) with the use of carbamazepine. On the other hand, muscular strength, tact and perception of temperature were deteriorated with the use of diclofenac. CONCLUSIONS it is important to provide the appropriate treatment to diabetic patients with DN.
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Area-under-the-HbA1c-curve above the normal range and the prediction of microvascular outcomes: an analysis of data from the Diabetes Control and Complications Trial.
Maple-Brown, LJ, Ye, C, Retnakaran, R
Diabetic medicine : a journal of the British Diabetic Association. 2013;(1):95-9
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Abstract
AIMS: In the Diabetes Control and Complications Trial, mean updated HbA(1c) accounted for most of the differential risk of microvascular complications between intensive and conventional insulin therapy. We hypothesized, however, that a more precise measure of chronic hyperglycaemic exposure may be the incremental area-under-the-HbA(1c)-curve above the Diabetes Control and Complications Trial-standardized normal range for HbA(1c) (iAUC(HbA1c>norm)). METHODS Using the Principal Diabetes Control and Complications Trial data set, we compared the following three measures of chronic glycaemic exposure for their capacity to predict retinopathy, nephropathy and neuropathy during the Diabetes Control and Complications Trial: mean updated HbA(1c), iAUC(HbA1c>norm), and total area-under-the-HbA(1c)-curve (tAUC(HbA1c)). For each outcome, models using each of these three glycaemic measures were compared in the following three ways: hazard or odds ratio, χ(2) statistic, and Akaike information criterion. RESULTS The three glycaemic measures did not differ in their prediction of neuropathy. iAUC(HbA1c>norm) was modestly superior to mean updated HbA(1c) for predicting nephropathy (χ(2) P = 0.017, Akaike P = 0.032). In contrast, for predicting retinopathy, both iAUC(HbA1c>norm) (χ(2) P = 0.0005, Akaike P = 0.0005) and tAUC(HbA1c) (χ(2) P = 0.004, Akaike P = 0.004) were significantly better than mean updated HbA(1c). Varying its HbA(1c) threshold incrementally between 37 and 53 mmol/mol (5.5-7.0%), inclusive, did not improve the prediction of retinopathy by iAUC(HbA1c>threshold) beyond that of tAUC(HbA1c,) consistent with the concept of a continuous relationship between glycaemia and retinopathy, with no glycaemic threshold. CONCLUSIONS Both iAUC(HbA1c>norm) and tAUC(HbA1c) were superior to mean updated HbA(1c) for predicting retinopathy. Optimal assessment of chronic glycaemic exposure as a determinant of retinopathic risk may require consideration of both the degree of hyperglycaemia and its duration.
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[Long-term effect of 3-week intravenous alpha-lipoic acid administration in symptomatic diabetic polyneutropathy with clinical manifestations].
Ametov, AS, Novosadova, MV, Barinov, AN, Samigullin, R, Trischler, HJ
Terapevticheskii arkhiv. 2010;(12):61-4
Abstract
AIM: To estimate the late duration of the effect of 3-week intravenous alpha-lipoic acid (alpha-LA) administration. SUBJECTS AND METHODS The study included patients with symptoms of myodiabetic polyneuropathy. The authors studied trends in neuropathic symptoms by the TSS scale and neuropathic deficit by the NIS-LL scale after 3-week intravenous alpha-LA (600 mg/day) administration. Control follow-up visits were made at weeks 8 and 30 of the study. RESULTS In alpha-LA-treated patients, the mean TSS score dropped from 9.46 +/- 1.01 to 3.29 +/- 1.49 after intravenous alpha-LA administration and continued to decrease to 260 +/- 1.18 and 4.39 +/- 201 scores at follow-up weeks 8 and 30, respectively. In the placebo group, these were 9.78 +/- 1.23, 6.16 +/- 1.95, 6.52 +/- 1.61, and 736 +/- 1.31 scores at weeks 3, 8, and 30, respectively; p < 0.05). In the alpha-LA group, NIS-LL scores fell from 8.65 +/- 3.46 to 6.01 +/- 3.12 at therapy week 3, to 6.11 +/- 3.36, at week 8, and to 7.68 +/- 3.68 at week 30 and in the placebo group, these decreased from 8.35 +/- 3.84 to 7.81 +/- 3.51, 7.89 +/- 3.72, and 8.32 +/- 3.49 scores at weeks 3, and 8, respectively; p < 0.05). CONCLUSION . Alleviated neuropathic symptoms persisted within 6 months after 3-week intravenous alpha-LA injection. Reduced neuropathic deficit did within 8 weeks after initiation of alpha-LA therapy.
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Effectiveness and safety of a novel gel dressing in the management of neuropathic leg ulcers in diabetic patients: a prospective double-blind randomized trial.
Abbruzzese, L, Rizzo, L, Fanelli, G, Tedeschi, A, Scatena, A, Goretti, C, Macchiarini, S, Piaggesi, A
The international journal of lower extremity wounds. 2009;(3):134-40
Abstract
Neuropathic leg ulcers (NLUs) affect more than 10% of diabetic patients with peripheral neuropathy and represent the most common cause of ulceration of the leg in these patients. Though their pathogenesis is well known, related to the chronic neuropathic edema, the management of NLUs, mainly based on elastocompression, is still controversial, with lower healing rates than nondiabetic venous leg ulcers. The authors tested if a novel gel formulation, containing amino acids and hyaluronic acid (Vulnamin)gel; Errekappa, Milan, Italy), will improve the outcomes of NLUs when used together with elastocompression. Thirty patients affected by NLU were randomized into 2 groups, both treated with 4-layer elastocompressive bandaging: patients in group A were topically treated with the application of Vulnamin) gel, whereas patients in group B received only the inert gel vehicle. The healing rate at 3 months was evaluated as the primary endpoint, whereas the secondary endpoints were healing time, reduction in ulcer area and ulceration score in 4 weeks, number of infective complications, and overall satisfaction of patients. Healing rate was significantly (P < .05) higher in patients in group A when compared with those in group B; healing time, patients' satisfaction, and reduction in ulcer area and ulceration score in 4 weeks were also higher in patients in group A. However, no significant differences were found in the prevalence of infections and other adverse events. The use of Vulnamin) gel with elastocompression is safe and effective in the management of NLUs of diabetic patients.
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Validation of a novel screening device (NeuroQuick) for quantitative assessment of small nerve fiber dysfunction as an early feature of diabetic polyneuropathy.
Ziegler, D, Siekierka-Kleiser, E, Meyer, B, Schweers, M
Diabetes care. 2005;(5):1169-74
Abstract
OBJECTIVE To validate a handheld screening device (NeuroQuick) for an early detection of diabetic distal symmetric polyneuropathy (DSP) by quantitative testing of cold sensation based on the wind chill factor (NeuroQuick threshold [NQT]). RESEARCH DESIGN AND METHODS NQT was measured on the dorsum of the foot in 160 healthy subjects as well as 60 and 128 diabetic patients without and with DSP, respectively. DSP was diagnosed by a neurological examination, motor and sensory nerve conduction velocity, vibration perception threshold, and warm and cold thermal perception threshold (TPT) (TPT Medoc). In addition, a C-64 Hz tuning fork and TipTherm device were used as screening instruments. RESULTS In the diabetic cohort, NQT correlated significantly with all nerve function tests, with the highest correlation coefficients being found on the foot versus Medoc warm TPT (r = 0.618, P < 0.001) and cold TPT (r = 0.529, P < 0.001). Among patients with DSP, NQT was abnormal, whereas Medoc warm TPT was normal in 34%, whereas only 5% showed the opposite constellation (P < 0.05). Likewise, the corresponding percentages for Medoc cold TPT were 32 and 11%, for TipTherm 47 and 2%, and for the tuning fork 29 and 10% (all P < 0.05), whereas no significant differences were noted when comparing NQT with peroneal motor nerve conduction velocity, sural sensory nerve conduction velocity, and malleolar vibration perception threshold. The coefficients of variation for repeated NQT measurements in 41 control and 41 diabetic subjects were 20.4 and 8.5%, respectively. CONCLUSIONS The NeuroQuick is a valid and reliable screening tool for quantitative assessment of small nerve fiber dysfunction. This device appears to be more sensitive in detecting early diabetic polyneuropathy than both elaborate thermal testing and screening tests such as the tuning fork.
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Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial.
Lesser, H, Sharma, U, LaMoreaux, L, Poole, RM
Neurology. 2004;(11):2104-10
Abstract
OBJECTIVE Pregabalin, an alpha2-delta ligand with analgesic, anxiolytic, and anticonvulsant activity, has been evaluated for treatment of neuropathic pain. The authors assessed the efficacy and tolerability of pregabalin (75, 300, 600 mg/day) vs placebo in patients with diabetic peripheral neuropathy (DPN). METHODS Patients with a 1- to 5-year history of DPN and average weekly pain score of > or =4 on an 11-point numeric pain-rating scale were enrolled in a 5-week, double-blind, multicenter, placebo-controlled study. Patients (n = 338) were randomized to receive one of three doses of pregabalin or placebo TID. Pregabalin 600 mg/day was titrated over 6 days; lower doses were initiated on day 1. RESULTS Patients in the 300- and 600-mg/day pregabalin groups showed improvements in endpoint mean pain score (primary efficacy measure) vs placebo (p = 0.0001). Improvements were also seen in weekly pain score, sleep interference score, patient global impression of change, clinical global impression of change, SF-McGill Pain Questionnaire, and multiple domains of the SF-36 Health Survey. Improvements in pain and sleep were seen as early as week 1 and were sustained throughout the 5 weeks. Responders (patients with > or =50% reduction in pain compared to baseline) were 46% (300 mg/day), 48% (600 mg/day), and 18% (placebo). Pregabalin was well tolerated with a low discontinuation rate. The most common adverse events were dizziness and somnolence. CONCLUSIONS In patients with diabetic peripheral neuropathy, pregabalin demonstrated early and sustained improvement in pain and a beneficial effect on sleep, which were confirmed by positive patient global impression. Pregabalin was well tolerated at all doses.
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Role of C-nociceptive fibers in the nerve axon reflex-related vasodilation in diabetes.
Caselli, A, Rich, J, Hanane, T, Uccioli, L, Veves, A
Neurology. 2003;(2):297-300
Abstract
OBJECTIVE To evaluate the role of the C-nociceptive nerve fibers in nerve axon reflex-related vasodilation. METHODS Skin vascular reactivity, in response to iontophoresis of acetylcholine and sodium nitroprusside, was evaluated at both the forearm and the foot levels in 13 diabetic neuropathic (DN),11 nonneuropathic (D), and 9 healthy control (C) subjects. The total and nerve axon reflex-related vasodilation were measured by two single-point laser probes. A topical anesthetic was applied on the contralateral forearm and foot, and all the measurements were repeated. RESULTS Dermal anesthesia resulted in a reduction of the nerve axon reflex-related vasodilation at the forearm in all three groups (C 70.7 +/- 12%, D 59.7 +/- 7%, and DN 73.5 +/- 14%; percentage of reduction over preanesthesia response, mean +/- SEM; p < 0.001) and at the foot in the two nonneuropathic groups (C 74 +/- 10% and D 68.9 +/- 9%; p < 0.001 versus before anesthesia). This reduction was absent at the foot of the neuropathic patients (DN -4 +/- 21%; p = NS versus before anesthesia). A correlation was found between the nerve axon reflex-related response and measurements of nerve function (neuropathy disability score, r = -0.425, p < 0.017; vibration perception threshold, r = -0.527, p < 0.002; Semmes-Weinstein monofilament perception, r = -0.619, p < 0.001). CONCLUSION The nerve axon reflex-related vasodilation is directly related to the function of the C-nociceptive fibers and is significantly associated with other nerve function measurements. As this is an objective measurement, it has the potential to be used as an alternative to currently employed techniques to evaluate small-fiber function.