Nicotinamide Riboside for Diabetic Neuropathy

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test NAD+.

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.

It had two arms (groups): Placebo (placebo comparator) and Niagen® (experimental).

The registry classes the interventions as drug.

More on the Plan

Previous failed trials of therapy have often targeted individuals with advanced, severe neuropathy.

There is a particularly strong incentive to treat neuropathy early in its course while the severity is still mild and to target participants who have impaired glucose tolerance (IGT) or who have well controlled type 2 diabetes mellitus (T2DM).

The proposed study design employs a quantifiable early measure of DN, intraepidermal nerve fiber density (IENFD) of the thigh, allowing for accurate assessment of actual nerve fiber density over time, while also incorporating measures of pain and quality of life.

Preclinical data supports the use of NR as a potential therapy for diabetic neuropathy.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Impaired glucose tolerance or controlled type 2 diabetes mellitus at the time of screening or within three months of screening\*. 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.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: patient must agree to take an alternative medication to warfarin or factor x inhibitors when undergoing a skin biopsy; neuropathy due to factors other than type 2 diabetes mellitus based on careful clinical and laboratory evaluation by the study physicians; abnormal liver function tests, including alanine transaminase, aspartate transaminase, alkaline phosphatase, and bilirubin.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-01-24 with completion listed for 2022-05-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Thigh Intraepidermal Nerve Fiber Density (time frame: 6 months).

It also tracked 1 secondary outcome, for example Distal lower limb intraepidermal nerve fiber density.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of NAD+ in 10 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.