Diabetic painful peripheral neuropathy
Conditions
Interventions
Product Name: Taurine
Pharmaceutical Form: Capsule, hard
CAS Number: 107-35-7
Other descriptive name: 2-aminoethanesulfonic acid
Concent
Sponsors
University of Birmingham, Research & Enterprise Services
Heart of England NHS Foundation Trust Birmingham Heartlands Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for subjects: 1. Type 1 or type 2 diabetes as defined by the World Health Organization Classification. 2. Duration of diabetes of at least 5 years. 3. The HbA1c should be =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects: 1. Nursing mothers, pregnant women (excluded by a negative pregnancy test). 2. Patients with a history of drug or alcohol dependence in the last 5 years 3. Patients with pre-existing cardiovascular disease. Patients with hypoxemic disease. 4. Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain 5. Patients with symptoms of neuropathic pain in the upper limbs alone 6. Significant changes in skin conditions in the areas to be tested which could alter sensation. 7. Subjects with a previous history of neuropathic foot ulceration or Charcot arthropathy 9. Patients currently taking medications that could affect symptoms of painful DN except acetominophen (up to 3g/d) or aspirin (up to 325 mg/d). 10 Patients experiencing an increase in pain after analgesic medication washout to levels which would, in the view of the PI, require prohibited analgesic therapy within a 12 wk period. 11. Patients whose creatinine clearance is less than 70 ml/min or have significant hepatic disease (AST, ALT, ?GT >2 times upper limit for normal). Patients with TSH outside normal limits 12. Patients with a history of previous kidney, pancreas or cardiac transplantation. 13. Serious or unstable medical or psychological state that may interfere with study participation. 14. Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study. 15. Morbidly obese patients (BMI greater than 40). 16. Patients who refuse to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to determine whether neuropathic pain in diabetes can be decreased with the use of taurine through subjective pain measures and electrophysiological measurements. ;Secondary Objective: It's second aim is to determine if the reduction of pain can improve mood and quality of life in patients with diabetes.; Primary end point(s): The proposed design is a randomized, double-blind clinical trial of taurine versus placebo, with the primary outcomes being pain and cold detection threshold. 1. Short-Form McGill-Melzack Pain Questionnaire: A SF-MMPQ is used to determine the effects of taurine treatment on qualitative aspects of pain perception. The SF-MMPQ comprises a sensory score, an affective score and a total score for various pain descriptors; a visual analogue scale (VAS) to assess overall pain intensity and a present pain rating intensity index (PPI). The SF-MMPQ contains 15 descriptions of pain, 11 of which represent the sensory dimension of painful experience and 4 of which represent the affective dimension. Each of these pain descriptions is then ranked by the subject on a 4 point scale and totally within subclasses. The overall intensity of the pain is scored using the 6-point PPI and the VAS. This questionnaire, together with the daily pain diaries, the clinical and patient global assessment of change, forms the basis of the assessment of changes in pain in this study. 2. Mean Sleep Interference Score: Decreased nocturnal pain perception may be associated with improved sleep. This will be assessed using a standardized sleep interference score. Mean sleep interference scores are calculated at baseline (ie the week preceding the randomization visit) and for the final week of the study (between visits B and C). The diary that is utilized for sleep assessment comprises a daily diary with an 11-point Likert-type scale which describes the degree to which the subject’s pain has interf | — |
Countries
United Kingdom
Outcome results
None listed