drugset / Trial / NCT03685253

Nicotinamide Riboside for Diabetic Neuropathy

NCT03685253

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2019-01-24
Primary completion
2022-05-01
Completion
2022-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotinamide riboside Small molecule 1000 mg