Taurine and painful diabetic neuropathy

• Register: ISRCTN
• Last refreshed on: 20 February 2017
• Main ID: ISRCTN49416618
• Date of registration: 14/03/2008
• Prospective Registration: No
• Primary sponsor: University of Birmingham (UK)
• Public title: Taurine and painful diabetic neuropathy
• Scientific title: Taurine and painful diabetic neuropathy
• Date of first enrolment: 01/10/2006
• Target sample size: 180
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN49416618
• Study type: Interventional
• Study design: Randomised blinded parallel two-group clinical study (Treatment)
• Phase: Not Specified

Countries of recruitment

United Kingdom

Contacts

• Name: Martin J. Stevens

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic neuropathy
Nervous System Diseases
Diabetic neuropathy

Intervention(s)

Taurine 3,000 mg/day (3 capsules) orally vs placebo 3 capsules daily for 12 weeks

Primary Outcome(s)

1. Pain perception is measured using the Short-Form McGill-Melzack Pain Questionnaire (SF-MMPQ), a Visual Analogue Scale (VAS) and a Present Pain rating Intensity index (PPI) at baseline, 4, 8 and 12 weeks
2. Pain is measured using 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(s)

1. Sleep is measured using the Mean Sleep Interference Score on a daily basis upon awakening
2. Mean Pain Scores are measured using daily diaries which comprise an 11-point Likert-type scale which ranges from 0 (no pain) to 10 (worst possible pain) upon awakening
3. Change in the subjects overall status is measured using the Clinical and Patient Global Impression of Change at baseline, 4, 8 and 12 weeks

Secondary ID(s)

RG 05-126

Source(s) of Monetary Support

National Institutes of Health (USA)