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| [ ...Back to search results ] | [ Print-friendly version ] |
| Taurine and painful diabetic neuropathy |
| Source of record | UK Trials |
| ISRCTN | ISRCTN49416618 |
| Date ISRCTN assigned | 14/03/2008 |
| Local reference number(s) | RG 05-126 |
| Public title | Taurine and painful diabetic neuropathy |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Diabetic neuropathy |
| Study hypothesis | Our overall hypothesis is that taurine depletion contributes to the development of painful Diabetic Neuropathy (DN). The rationale is based on: a. Evidence implicating oxidative stress, altered neuronal calcium signaling and neuronal hyperexcitability in the development of painful DN b. The emerging role of taurine as an important endogenous antioxidant, calcium regulator, neurotrophin, modulator of neuronal hyperexcitability and analgesic c. Our data implicating a critical role for taurine depletion and oxidative stress in the pathogenesis of experimental DN. The experimental approach will be to utilize biochemical and electrophysiological techniques to evaluate the potential of taurine treatment alone to decrease pain in patients with DN. These studies will test a novel mechanistically-based therapeutic approach to a common disabling and often refractory complication of diabetes. |
| Design/methodology | A randomised, blinded, parallel two-group clinical study. |
| Research ethics review | Leeds (East) Research Ethics Committee, approved on 22/09/2006. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 <10.5% with <1% fluctuation of HbA1c levels over the past 6 months 4. Age between 18 and 80 years 5. Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study 6. Must meet the specified criteria for painful DN and have no risk factors for other causes for neuropathy 7. Willingness to sign the Center for Research Ethics Committee (COREC) approved informed consent form |
| Participants - exclusion criteria | 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 4. Patients with hypoxemic disease 5. Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain 6. Patients with symptoms of neuropathic pain in the upper limbs alone 7. Significant changes in skin conditions in the areas to be tested which could alter sensation 8. Subjects with a previous history of neuropathic foot ulceration or Charcot arthropathy 10. Patients currently taking medications that could affect symptoms of painful DN except paracetamol (up to 4 g/d) or aspirin (up to 325 mg/d) 11. 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 week period 12. Patients whose creatinine clearance is less than 70 ml/min or have significant hepatic disease (Aspartate aminotransferase [AST], alanine aminotransferase [ALT], y-GT >2 times upper limit of normal) 13. Patients with thyroid stimulating hormone (TSH) outside normal limits 14. Patients with a history of previous kidney, pancreas or cardiac transplantation 15. Serious or unstable medical or psychological state that may interfere with study participation 16. 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 17. Morbidly obese patients (Body Mass Index [BMI] greater than 40) 18. Patients who refuse to sign the informed consent |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/10/2006 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Ongoing |
| Target number of participants | 180 |
| Interventions | Taurine 3,000 mg/day (3 capsules) orally vs placebo 3 capsules daily for 12 weeks |
| Primary outcome measure(s) | 1. Short-Form McGill-Melzack Pain Questionnaire (SF-MMPQ) at baseline, 4, 8 and 12 weeks: 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. 2. Daily pain diaries, recorded for 12 weeks. 3. Physician and Patient Global Assessment of Change, assessed at 12 weeks post inclusion into the study (final assessment) |
| Secondary outcome measure(s) | 1. 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 (i.e. the week preceding the randomization visit) and for the final week of the study (between visits B [physical exam] and C [neurological exam]). 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 interfered with sleep during the preceding 24 h. The scale ranges from zero (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). The assessment is performed on a daily basis upon awakening. The end-point mean sleep interference score is calculated as the mean score for the last 7 dairy entries while the subject was taking the study drug. 2. Mean Pain Scores from Screening to Study End: The subjects daily diaries are used to compute the mean pain scores in each treatment group from the screening visit to the study end. The daily diary comprises an 11-point Likert-type scale which ranges from 0 (no pain) to 10 (worst possible pain). The degree of neuropathic pain that has been experienced by the subject is rated by selecting a number from 0 to 10. This diary is completed upon awakening. The end-point mean pain score is calculated as the mean score for the last 7 dairy entries while the subject was taking the study drug. 3. Clinical and Patient Global Impression of Change: These measures of global impression of change are evaluated by both the physician and the patient at the final visit (physical exam). The Clinical Global Impression of Change is a clinician-rated instrument which measures the change in the subjects overall status on a 7-point scale which ranges from 1 (very much improved) to 7 (very much worse). In parallel, the subject completes a Patient Global Impression of Change which measures the subjects overall status using a similar 7-point scale. |
| Sources of funding | National Institutes of Health (USA) |
| Sponsor name | University of Birmingham (UK) |
| Sponsor details | The Medical School Institute for Biomedical Research Edgbaston Birmingham United Kingdom B45 8PF |
| Sponsor telephone | +44 (0)121 414 8162 |
| Sponsor fax | +44 (0)121 414 6919 |
| Sponsor email | m.j.stevens@bham.ac.uk |
| Sponsor website | http://www.bham.ac.uk/ |
| Contact name | Prof Martin J. Stevens |
| Contact details | University of Birmingham The Medical School Institute for Biomedical Research Edgbaston Birmingham United Kingdom B45 8PF |
| Contact telephone | +44 (0)121 414 8162 |
| Contact fax | +44 (0)121 414 6919 |
| Contact email | m.j.stevens@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN49416618 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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