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Biomedical subjects

C Laudadio

Publications and source records attributed to C Laudadio.

7 recordsLinked to original sources

A cross-sectional study comparing two quantitative sensory testing devices in individuals with diabetes.

OBJECTIVE: This study was designed to compare circumference discrimination thresholds, as assessed by the Tacticon (Tacticon, Inc., Westtown, PA), a new quantitative sensory testing (QST) device, with vibratory thresholds, an assessment modality of large sensory nerve fibers, in individuals with diabetes. RESEARCH DESIGN AND METHODS: In this study, 150 individuals with diabetes were evaluated. Vibratory thresholds and circumference discrimination thresholds, evaluated with the Tacticon, were determined using a two-alternative forced-choice procedure. RESULTS: Vibratory thresholds increased with decreasing ability to discriminate differences in circumference (P < 0.001) for those below and above 50 years of age. Agreement between the two QST devices was assessed via the kappa-statistic in both age-groups (i.e., < or = 50 years old [kappa = 0.67], > 50 years old [kappa = 0.55]). In multiple logistic regression, where circumference discrimination thresholds were the dependent variable, age, duration of diabetes, and height were found to be independently associated for those > 50 years old. CONCLUSIONS: The Tacticon offers a simple method of assessing the complex function of area discrimination. Our results suggest that the Tacticon can detect neuropathy in the primary care setting. Its cost, portability, and ease of use provide some advantages over existing QST equipment.

Adult↗

Design of controlled clinical trials for diabetic polyneuropathy.

Diabetic neuropathy is a common and debilitating complication of diabetes mellitus associated with high health costs. In recent years several clinical trials have been undertaken to test the efficacy of drug intervention in this disorder. The results of these trials have in general been disappointing. In this review we discuss selection criteria, efficacy endpoints, duration of clinical trials, and data collection and analyses. We offer suggestions based on past experiences that might improve trial design and execution in order to achieve improved results from treatment of this silent but common disorder.

Controlled Clinical Trials as Topic↗

The effects of age and diabetes mellitus on nerve function.

OBJECTIVE: This project evaluated the association of age and vibratory thresholds (assessment modality of large sensory nerve fibers) in subjects with and without diabetes mellitus. DESIGN: Cross-sectional study. SETTING: Medical Research Institute of Delaware. PARTICIPANTS: Individuals with non-insulin-dependent diabetes mellitus and non-diabetic control subjects. MEASUREMENTS: Vibratory thresholds were examined in four age groups (ie, < 45 yrs, 45-54 yrs, 55-64 yrs, > or = 65 yrs). The independent association of age, duration of diabetes, height, gender, glycemic control, and smoking history were analyzed in terms of their relationship to vibratory thresholds. MAIN RESULTS: Vibratory thresholds increased with age for both control and diabetic subjects. Comparing controls with diabetic subjects in the same age categorizes revealed significant differences for vibratory thresholds only in the > or = 65 year old age group. Modeling with vibratory thresholds as the dependent variable showed that age and male gender were independently associated with vibratory thresholds for the controls and explained the majority of the variability (R2 = 0.79). Age, duration of diabetes, and height were independently associated with vibratory thresholds for the diabetic subjects but explained much less of the variability (R2 = 0.39). CONCLUSIONS: The results suggest an acceleration of the natural aging process for large sensory nerve fiber function in diabetic subjects. Thus, young diabetic subjects may be at a risk of lower extremity complications as a result of injuries similar to that older non-diabetic individuals.

Adult↗

The reproducibility and sensitivity of sural nerve morphometry in the assessment of diabetic peripheral polyneuropathy.

The nerve fibre loss, atrophy and injury of diabetic peripheral polyneuropathy and their responses to metabolic intervention have been studied by morphometric analysis of sural nerve biopsies. The magnitudes and sources of intra- and inter-individual variation in these morphometric measures have not been investigated previously in a systematic manner. Morphometric parameters of nerve fibre damage were measured in four separate fascicles from bilateral sural nerve specimens obtained post-mortem from 13 diabetic and 13 non-diabetic subjects. Intra- and inter-individual coefficients of variation were computed and compared to the magnitude of the differences between normal and diabetic subjects. Several morphometric variables emerged as highly sensitive and reproducible measures of nerve fibre damage suitable for clinical studies of diabetic peripheral polyneuropathy. These observations provide a rational basis for the design of future clinical trials employing morphometric end-points.

Autopsy↗

Thermal sensitivity tester. Device for quantitative assessment of thermal sense in diabetic neuropathy.

The Thermal Sensitivity Tester (TST) is a portable device designed to quantify the ability to discriminate small differences in temperature at the distal extremities of the hands and feet. The testing surfaces are two identical nickel-coated copper plates, which can be set and maintained over a wide range of temperature levels. The threshold for detecting the colder surface is determined using a two-alternative, forced-choice algorithm. The mean threshold in the normal population is 0.67 degree C and 1.01 degree C for the index finger and great toe, respectively. The TST is especially useful in diabetic neuropathy and for rapid screening of large populations under field conditions.

Adult↗

Progression rates of diabetic neuropathy in placebo patients in an 18-month clinical trial. Ponalrestat Study Group.

Recent clinical drug trials designed to test the effect on established mild diabetic neuropathy have in general been disappointing. These findings may in part be due to a failure of tested drugs to reverse neuropathy (they may merely halt its progression) and to insufficient durations of the trials. To aid the design of future studies, we examined the progression rates of quantitative sensory tests, autonomic functions, and sensory and motor nerve electrophysiology in 182 patients designed to placebo treatment in an 18-month multicenter ARI-trial. Clinically meaningful deteriorations were demonstrated in the vibratory perception threshold in the toe and the Valsalva ratio. The greatest deterioration rate in electrophysiologic measures was found in peroneal F-wave latency and in sensory nerve conduction velocities in the upper limb, but none of these reached the threshold of clinically meaningful change. Assuming that drug efficacy will be based on the deterioration rates in placebo patients alone, the present data suggest a minimum of 250 patients treated for at least 2 years to achieve convincing efficacy.

Diabetic Neuropathies↗