Nicotinamide Riboside for Diabetic Neuropathy

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: US Department of Veterans Affairs
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

1. Impaired glucose tolerance or controlled type 2 diabetes mellitus at the time of screening or within three months of screening*.

2. The hemoglobin A1c may be normal, but should be less than 9%.

3. 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.

4. Impaired glucose regulation is the most likely cause of the neuropathy.

5. Mild diabetic polyneuropathy as defined by the Toronto Diabetic Neuropathy Expert Group consensus criteria.

6. Age 30 (to exclude patients with type 1 diabetes) to 80 years inclusive.

7. Medically stable at the time of enrollment.

8. Willing to accept randomization assignment and compliance with the study procedures.

Exclusion Criteria:

1. Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study.

2. Patient must agree to take an alternative medication to Warfarin or Factor X inhibitors when undergoing a skin biopsy.

3. Neuropathy due to factors other than type 2 diabetes mellitus based on careful clinical and laboratory evaluation by the study physicians.

4. Abnormal liver function tests, including alanine transaminase, aspartate transaminase, alkaline phosphatase, and bilirubin.

5. Current severe medical conditions that are active on the day of screening.