Improving quality of life for people with diabetic neuropathy through dietary education and therapy
Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy
This study is testing if adding dietary education about a gluten-free diet to a therapy for nerve pain can help adults with diabetic neuropathy feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05165368 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of combining dietary education with Intraneural Facilitation® Therapy (INF® Therapy) in adults suffering from distal symmetric polyneuropathy (DSPN) due to Type II diabetes. Participants will be randomly assigned to receive either INF® Therapy alone or INF® Therapy along with dietary education focused on a gluten-free diet. The study will assess pain levels and dietary compliance through questionnaires and visual analog scales. The goal is to determine if the addition of dietary education enhances the therapeutic effects of INF® Therapy.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 50 to 75 with Type II diabetes and moderate to severe distal symmetric polyneuropathy.
Not a fit: Patients currently on a mainly plant-based or gluten-free diet, or those with certain serious medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with diabetic neuropathy by reducing symptoms and enhancing overall well-being.
How similar studies have performed: While the combination of dietary education and physical therapy is a novel approach, similar studies have shown promise in improving outcomes for neuropathy patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 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 Exclusion Criteria * 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 this trial is running
Loma Linda, California
- Loma Linda University Health — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Eric G Johnson, DSc, MS-HPEd — Department of Physical Therapy School of Allied Health Professions, Loma Linda University
- Study coordinator: Criss R Carlson, DPT
- Email: crcarlson@llu.edu
- Phone: 909-233-8140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.