Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy
Completed · Not applicable
Conditions studied: Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)
In brief
The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation® Therapy (INF® Therapy) (a physical therapy technique being evaluated that may help improve circulation) versus INF® Therapy only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).
Key facts
- Study ID
- NCT05165368
- Run by
- Loma Linda University
- People needed
- 46
- Starts
- 2023-08-01
- Expected to finish
- 2025-05-20
- Last updated by the study team
- 2025-08-14
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants in this study must be/have:
- Older adults between 50 to 75 years of age
- Willing to actively improve neuropathy symptoms
- Diagnosed with Type II diabetes
- Moderate to severe DPN (diabetic peripheral neuropathy) with symptoms below the knees of numbness, tingling, burning, sharp pain, and/or increased sensitivity
- Distal Symmetric Polyneuropathy (DSPN) form of DPN
- Independent in daily activities
- Do not use any assistive device for walking such as a cane, walker, or wheelchair
You may not qualify if…
- Currently consuming a mainly plant-based or gluten-free diet
- Known allergy to chrome, nickel, or cobalt
- Any of the following medical conditions:
- Current regimen of chemotherapy, radiation, or dialysis
- Lower extremity amputations and open wounds
- Documented active drug and/or alcohol misuse
- End stage renal failure
- End stage congestive heart failure
- Uncontrolled hypertension
- Chronic liver disease
- Advanced chronic obstructive pulmonary disease
- Active inflammations
- Other types of neuropathies not associated with diabetes including B12 deficiency
- Any other chronic medical conditions requiring active treatment
- Morbid obesity
- Pregnancy (self-reported)
Where it is running
- Loma Linda University Health — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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