Nicotinamide Riboside for Diabetic Neuropathy (NiRiD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03685253|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy Peripheral||Drug: Niagen Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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, 2024|
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.
Placebo capsules matched to the experimental drug and taken orally as 2 capsules twice daily for 6 months.
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
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.
- 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.
- 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.
- Modified Toronto Clinical Neuropathy Scale [ Time Frame: 6 months. ]Modified Toronto Clinical Neuropathy Scale to assess clinical symptoms and signs of diabetic neuropathy
- Total Neuropathy Score (Clinical) [ Time Frame: 6 months. ]Total Neuropathy Score (Clinical)
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Neda M Ilieva, B.S.||(410) email@example.com|
|United States, Maryland|
|University of Maryland||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Neda M Ilieva, B.S. 410-328-6583 firstname.lastname@example.org|
|Contact: James W Russell, MD (410) 328-3100 email@example.com|
|Principal Investigator: James W Russell, MD|
|Sub-Investigator: Lindsay A Zilliox, MD|
|Principal Investigator:||James W Russell, MD||University of Maryland School of Medicine & Department of Veterans' Affairs|