The Treatment of Painful Diabetic Neuropathy With Diet
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth
About this trial
The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function.
This study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4)
objective documentation of peripheral neuropathy on EMG/NCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less
presence of painful neuropathy in addition to decreased sensation
with pain rated ≥4/10 on a 0-10 numerical rating scale (NRS)
Disqualifiers
Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
type I diabetes
vitamin B12 deficiency
folate deficiency
Trial design
Design model
Crossover
Treatments tested in this trial
Diet
Other interventionPlant-based diet
Medical management
Other interventionMedication optimization
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Diet armExperimental treatment 1 intervention
Group B: medical managmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.
Time frame
2 months2
Average pain on Numerical Rating Scale (NRS)
Patient will be asked what his or her "average" pain has been over the last 3 days. This will be on the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Time frame
2 months3
≥50% improvement of pain
Patient will be asked if his or her average pain over the past 3 days is ≥50% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Time frame
2 months4
≥75% improvement of pain
Patient will be asked if his or her average pain over the past 3 days is ≥75% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Time frame
2 monthsSecondary outcomes
1
Worst Pain Score on Numerical Rating Scale (NRS)
Patient will be asked what his or her worst pain is on a daily basis using the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Time frame
2 months2
Numbness location
Patient asked the following: How far up does your numbness go in both lower extremities: (circle one): 1. Toes 2. Mid foot 3. Entire foot 4. Ankle 5. Mid calf 6. Knee
Time frame
2 months3
Sleep
Patient is asked the following questions. How is your sleep? Circle one: good moderate poor 1. How many hours are you sleeping a night? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. Is your sleep improved since the start of study? \_\_\_\_\_\_\_\_\_\_\_\_\_\_ (yes or no)
Time frame
2 months4
Diabetes medication
Patient is asked: List your diabetes medications and doses.
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov