View clinical trials related to Diabetic Neuropathy Peripheral.
Filter by:The goal of this clinical trial is to test in patients with diabetic neuropathy, - Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up. - Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg/day)+EPALRESTAT (150 mg/day) conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up - All potential participants will undergo screening- about 10 ml of blood will be drawn to perform the following assesments at screening- HbA1c, FBS,Vit B12, TSH, fT4. - Baseline assessments conducting a nerve conduction study, quality of life assesment using Eq-5D-5L and NRS pain score. - 20% of patients (24 patients) will undergo Sudoscan, Corneal confocal microscopy and a skin biopsy for assessing IENFD (Intra Epidermal Nerve Fibre Density). - 15th day, 1 month and 3rd month followup for evaluating patients status and medication adherance. - 6th month followup for evaluating patients status and medication adherance. Researchers will compare Nebivolol against combination of Epalrestat+Alpha Lipoic Acid against standard pain modulating treatment to evaluate their diseaes modifying effect as reflected by nerve conduction study parameters.
The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.
Diabetic peripheral neuropathy is the most common complication to diabetes mellitus affecting as much as 50% of the population with diabetes. Symmetrical sensory neuropathy is by far the most common pattern, which often progress slowly over many years, although some individuals experience faster and more severe courses. Despite the frequent occurrence, the causes of diabetic peripheral neuropathy are largely unknown, which is reflected in the fact that no disease-modifying treatments are available for preventing, treating or even halting the progression of the disease. The consequences can be dire, as neuropathy frequently leads to foot ulcers, amputations or intolerable neuropathic pain in the lower extremities. Sensory loss may go completely undetected in diabetes, as there often are literally no symptoms. For many individuals, the development of diabetic peripheral neuropathy can therefore proceed completely unnoticed, making regular screening the most important tool for diagnosing the condition. Unfortunately, unlike nephropathy or retinopathy, diabetic peripheral neuropathy is not easily screened for, as the condition lacks reliable markers for early- or progressing disease. Therefore, screening for diabetic peripheral neuropathy currently revolves around diagnosing loss of protective sensation, judged by the inability to feel vibration or light touch. However, in their most recent guidelines, the American Diabetes Association has included screening for small fibre neuropathy using either the cold- and heat perception thresholds or pinprick as a clinical standard. Although this acknowledgement of the importance of assessing not only large- but also small nerve fibres is a huge step towards early detection of diabetic peripheral neuropathy, the overriding issue of insensitive, unreproducible, and inaccurate bedside tests for small nerve fibres remains. While cold- and heat perception and pinprick sensation are indeed mediated by small nerve fibres, the sensitivity of these methods, outside of extreme standardization only achievable in dedicated neuropathy research-centres, remain poor and not usable on an individual level. This lack of sensitivity has also become apparent in several large clinical trials, where the methods have continuously failed as robust clinical endpoints. Due to this, the hunt for a sensitive and reproducible method for adequate assessment of the small nerve fibres have begun. Amongst several interesting methods, two have gained particular interest (corneal confocal microscopy and skin biopsies with quantification of intra-epidermal nerve fiber density), due to their diverse strengths, although clinical application is currently limited to a few specialized sites. Furthermore, both methods suffer several inherent issues including that fact that they only provide information about the structure of the nerves and not the function. One method to assess the function of small cutaneous C-fibers is the assessment of the axon reflex flare response using laser doppler imaging (LDI) or Full-field laser perfusion imaging (FLPI), which has classically been studied using local heating. Unfortunately, this method is limited in clinical usage due to time-consumption. The investigators recently published an alternative method using a simple skin-prick application of histamine to evoke the response, which reduced the examination-time markedly. Before claiming the method to be a better alternative, the investigators do however need to prove that the method is as good as the original. In addition to the direct comparison of the histamine-induced and the heating-induced axon-reflex flare response the study will also assess spatial acuity in the same cohort as a secondary aim. Spatial acuity is considered as a measure of the sensory systems ability to code spatial information regarding an external stimulus. To investigate the spatial acuity, the 2-point discrimination task (2PDT) is often used. Spatial acuity has been shown to be impaired in several chronic pain condition. Additionally, it has been shown that the 2PDT may be a useful tool to understand the sensory changes in diabetes[8].
Objectives: The goal of this cross sectional clinical trial is to examine the phenotype of bone disease in type 2 diabetes.The main aims are to: 1. Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures. 2. Examine how autonomic and peripheral neuropathy affects bone microarchitecture, bone material strength and bone turnover markers as well as postural control in T2D. Methods: The trial is of cross-sectional design and consists of examinations including - Blood samples to analyze bone markers, glycemic state i.e. - Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure. - Microindentation to evaluate bone material strength - Skin autofluorescence to measure levels of advanced glycation endproducts (AGEs) in the skin - Assesment of nerve function (peripheral and autonomic) - Assesment of postural control, muscle strength and gait Participants: A total of 300 type 2 diabetes patients divided to three groups: - 160 with no history of fractures or diabetic neuropathy - 100 with a history of fracture(s) - 40 with autonomic neuropathy or severe peripheral neuropathy
A prospective, randomized, controlled study will be conducted at Department of Endocrinology, Faculty of Medicine, Ain Shams University, assessing the efficacy of Ambroxol addition on the clinical outcome and inflammatory markers in Diabetic peripheral neuropathy patients
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy. The data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.
Neuropathy is a frequently observed complication occurring in 60-70% of diabetic patients throughout their lives. In addition, neuropathy is a severe disease that progresses insidiously; its diagnosis can be delayed due to the absence of clinical findings, affects the quality of life, and increases mortality and morbidity. Up to 50% of patients with diabetic peripheral neuropathy (DPN) may be asymptomatic. Typically, DPN progresses in the form of chronic, symmetrical, and progressive sensorimotor polyneuropathy. The five-year mortality rate of individuals with diabetes with autonomic neuropathy is three times higher than those without. The diagnosis of clinical neuropathy is usually made by the symptoms, the vibration sensation with the diapason, and the tactile sensation tests. Although diapason and monofilament tests are easy, they are qualitative tests that the patient must be careful and coordinate with. Biothesiometry or Semmes-Weinstein monofilament tests cannot examine autonomous involvement. Cardiovascular autonomic neuropathy tests based on heart rate variability (HRV), on the other hand, can be affected by factors such as age, body position, cigarette-coffee consumption, blood pressure, exercise, heart rate, and respiratory rate. An easy and fast diagnostic method may be more helpful in diagnosing peripheral and autonomic neuropathy. Distal small-fiber polyneuropathy can be detected by measuring sweat function using Sudoscan, a rapid, non-invasive, and quantitative method. This measurement method is based on the electrochemical reaction between sweat chlorides and stainless steel electrodes that come into contact with the palms of the hands and soles of the feet. Results are provided as a Diabetic Autonomic Neuropathy (DAN) score based on conductances (micro siemens, μS) and conductivity values for the hands and feet (right and left sides). SUDOSCAN can detect distal small-fiber polyneuropathy with >75% sensitivity. SUDOSCAN can be considered a robust method for detecting sudomotor dysfunction and is used for clinical and research purposes. In the American Diabetes Association (ADA) consensus statement, sudomotor functions are mentioned in the early diagnosis of autonomic neuropathy in people with diabetes. This study aimed to evaluate the effectiveness of this method in clinical applications by comparing sudomotor test results with other conventional measurement methods in the evaluation of diabetic peripheral and cardiac neuropathy.
This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).
Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study. The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.