Nicotinamide Riboside for Diabetic Neuropathy (NCT03685253) | Clinical Trial Compass
TerminatedPhase 1/2
Nicotinamide Riboside for Diabetic Neuropathy
Stopped: Completed the pilot study and grant funding not obtained to continue to the main phase 2 study. The pilot study did not show a statistical significance in the primary or secondary outcome measures.
United States10 participantsStarted 2019-01-24
Plain-language summary
At the current time there is no effective disease modifying therapy for diabetic neuropathy (DN). The proposed study design employs a quantifiable early measure of DN, intraepidermal nerve fiber density (IENFD), allowing for accurate assessment of actual nerve fiber density. Preclinical data supports the use of Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) as a potential therapy for diabetic neuropathy. Phase I data indicates safety in humans. This study seeks to investigate the use of Niagen® (NR) as a potential treatment for diabetic neuropathy in subjects with type 2 diabetes mellitus or impaired glucose tolerance over a 6 month period. The endpoint measures in addition to the IENFD with determine changes in clinical and electrophysiological outcomes, quality of life and biochemical measures.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. Impaired glucose tolerance or controlled type 2 diabetes mellitus at the time of screening or within three months of screening\*.
✓. The hemoglobin A1c may be normal, but should be less than 9%.
✓. If diabetic participants are on medication, they should be stable on medication for at least 3 months prior to entering the study. Addition or change in antidiabetic medication (if on medication) after enrollment does not affect participation or group assignment.
✓. Impaired glucose regulation is the most likely cause of the neuropathy.
✓. Mild diabetic polyneuropathy as defined by the Toronto Diabetic Neuropathy Expert Group consensus criteria.
✓. Age 30 (to exclude patients with type 1 diabetes) to 80 years inclusive.
✓. Medically stable at the time of enrollment.
✓. Willing to accept randomization assignment and compliance with the study procedures.