No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
AdventHealth · Other
Who this trial is looking for
This trial is looking for adults with painful diabetic neuropathy who have type 2 diabetes. Participants will follow a special plant-based diet and attend follow-up visits to see how it affects their symptoms.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesVitamin B12 deficiencyFolate deficiencyThyroid dysfunctionAutoimmune disordersHIV/AIDSModerate to severe lumbar stenosis with neurogenic claudication
You may be able to join if
I have been diagnosed with type 2 diabetes
I have painful neuropathy and decreased sensation
I am at least 18 years old
I can provide informed consent
I can attend follow-up visits
My HbA1c is 6.5 or higher or I have pre-diabetes
I have objective documentation of peripheral neuropathy
You may not be able to join if
I have been diagnosed with type 1 diabetes
I have a vitamin B12 deficiency
I have a folate deficiency
I have thyroid dysfunction
I have other nutritional deficiencies
I have an autoimmune disorder
I have HIV/AIDS
I have moderate to severe lumbar stenosis with neurogenic claudication
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 reve…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 de…
Inclusion Criteria:
* 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)
* age 18 years or older
* ability to provide informed consent
* ability to attend follow-up visits.
Exclusion Criteria:
* Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
* type I diabetes
* vitamin B12 deficiency
* folate deficiency
* thyroid dysfunction,
* other nutritional deficiencies
* autoimmune disorders
* inflammatory disorders
* HIV/AIDS
* exposure to metals or toxins
* multiple myeloma,
* moderate to severe lumbar stenosis with neurogenic claudication
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