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Nicotinamide Riboside for Diabetic Neuropathy (NiRiD)

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ClinicalTrials.gov Identifier: NCT03685253
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
James W. Russell, MD, MS, University of Maryland, College Park

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Peripheral Drug: Niagen Drug: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nicotinamide Riboside in Diabetic Polyneuropathy
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants randomized to placebo will take 2 capsules by mouth twice a day for 6 months. The placebo capsules are matched to the NR capsules.
Drug: Placebo
Placebo capsules matched to the experimental drug and taken orally as 2 capsules twice daily for 6 months.

Experimental: Niagen®
Participants randomized to Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) will take 250 mg capsules. Participants will take 2 capsules by mouth twice a day (1000 mg) for 6 months
Drug: Niagen
Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) will be the experimental treatment, at a dose of 1000 mg/day taken as two 250 mg capsules twice daily for 6 months.
Other Names:
  • Nicotinamide Riboside
  • 3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride




Primary Outcome Measures :
  1. Thigh Intraepidermal Nerve Fiber Density [ Time Frame: 6 months. ]
    Change in the proximal thigh Intra-Epidermal Nerve Fiber Density as assessed by skin biopsy. Smaller values indicate worse neuropathy. Normative ranges depend on age and gender.


Secondary Outcome Measures :
  1. Distal lower limb intraepidermal nerve fiber density [ Time Frame: 6 months. ]
    Change in the distal leg Intra-epidermal Nerve Fiber Density as assessed by biopsy. Smaller values indicate worse neuropathy. Normative ranges depend on age and gender.


Other Outcome Measures:
  1. Modified Toronto Clinical Neuropathy Scale [ Time Frame: 6 months. ]
    Modified Toronto Clinical Neuropathy Scale to assess clinical symptoms and signs of diabetic neuropathy

  2. Total Neuropathy Score (Clinical) [ Time Frame: 6 months. ]
    Total Neuropathy Score (Clinical)

  3. The Neuropathy Total Symptom Score (NTSS-6) [ Time Frame: 6 months. ]
    The Neuropathy Total Symptom Score ranges from 0 to 21.96 points with higher scores indicating a worse symptom score

  4. Pain Quality Assessment Scale [ Time Frame: 6 months. ]
    To evaluate the neuropathic pain and non-neuropathic pain. The Pain Quality Assessment Scale was developed from the neuropathy Pain Scale and is a 20 item scale that assesses both neuropathic pain and non-neuropathic pain. Higher score indicate worse pain.

  5. Survey of Autonomic Symptoms [ Time Frame: 6 months. ]
    Survey of Autonomic Symptoms to assess symptoms of peripheral autonomic function. The scale varies depending on gender. Higher scores indicate higher levels of autonomic symptoms.

  6. Neuro Quality of Life Measure [ Time Frame: 6 months. ]
    This measures quality of life and is an 11 item scale with each item scored from 0 to create an aggregate scale. High scores are worse.

  7. Nerve Conduction Studies [ Time Frame: 6 months. ]
    Nerve Conduction Studies to assess changes in nerve conduction. The amplitudes of the sural sensory, fibular motor, tibial motor and their respective distal latencies, and conduction velocities are obtained. Data will be used from individual measurements and using a mega score of combined variables. Lower scores may indicate neuropathy.

  8. Cardiac Autonomic Neuropathy [ Time Frame: 6 months. ]
    The expiration:inspiration ratio will be measured. Normative data varies depending on age, gender and other factors. Lower scores may indicate cardiac autonomic neuropathy.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685253


Contacts
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Contact: Neda M Ilieva, B.S. (410) 328-6583 inmed@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Neda M Ilieva, B.S.    410-328-6583    inmed@som.umaryland.edu   
Contact: James W Russell, MD    (410) 328-3100    jrussell@som.umaryland.edu   
Principal Investigator: James W Russell, MD         
Sub-Investigator: Lindsay A Zilliox, MD         
Sponsors and Collaborators
University of Maryland, College Park
US Department of Veterans Affairs
Investigators
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Principal Investigator: James W Russell, MD University of Maryland School of Medicine & Department of Veterans' Affairs

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Responsible Party: James W. Russell, MD, MS, Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03685253     History of Changes
Other Study ID Numbers: HP00080331
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James W. Russell, MD, MS, University of Maryland, College Park:
diabetes
neuropathy
treatment
drug

Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents