The Treatment of Painful Diabetic Neuropathy With Diet

Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.

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.

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.

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.

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.

Patient asked the following:

How far up does your numbness go in both lower extremities: (circle one):

• Toes
• Mid foot
• Entire foot
• Ankle
• Mid calf
• Knee

Patient is asked the following questions.

How is your sleep? Circle one: good moderate poor

• How many hours are you sleeping a night? ___________________
• Is your sleep improved since the start of study? ______________ (yes or no)

Patient is asked:

List your diabetes medications and doses.

Patient is asked the following question. List your pain medications and doses.

Patient is asked:

What percentage of has your pain improved compared to the start of the study? ____________ (0% = no change to 100% complete relief of pain)

What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement)

Have you been able to increase your function (walking, getting around, steadiness on feet)? _________ (yes or no)

If you are in the diet group, how compliant have you been with your diet? Chose one:

• 0% (not compliant at all)
• 25%
• 50%
• 75%
• 90%
• 100% (completely compliant at all times)

Rate your global impression of change of your diabetic neuropathy (chose one):

• Very much improved
• Much improved
• Moderately improved
• Minimally improved
• No change
• Worse
• Much worse
• Very much worse

Weight in pounds measured at baseline and two months. This is measured in clinic.

Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines.

Number of participants with abnormal heart rate (outside of normal 60-100/min)

Number of participants with abnormal creatinine lab level (above 1.3 for males, 1.1 for females) and correlating with estimated glomerular filtration rate which is based off creatinine, age and sex. Kidney function will be based on the National Kidney Foundation guidelines (KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease).

Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values.

Percent of patients with abnormal hemoglobin A1c. Abormal values are based on American Diabetes Association (normal <5.7, pre-diabetes 5.7-6.4, diabetes ≥6.5).