Muscarinic Receptor Antagonists as a Therapy for Diabetic Neuropathy

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Investigators propose a placebo controlled, double blinded study to examine efficacy of topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2 diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated efficacy of topiramate in reversing IENF loss within 18 weeks in our prior study. Subjects will also undergo quantitative sensory testing (QST) and assays of laser Doppler skin blood flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life (Norfolk QOL-DN), along with standard measures of physiology and fasting blood chemistry. Subjects with IENF loss of between 20-75% of normative values and thus amenable to therapy-induced recovery, will be randomized into placebo (N=30) or active drug (N=30) arms and instructed in how to apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2 region of skin adjacent to the initial biopsy site, as per the manufacturers instructions (http://www.gelnique.com/gel3/). Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance. After 20 weeks, subjects will return for a second series of measurements and 3 mm skin biopsy from the treated region of skin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborators: Impeto Medical; National Institutes of Health (NIH)
• Treatments: Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• Presence of type 2 diabetes

• Participants between the ages of 30 and 80

Exclusion Criteria:

1. Presence of type 1 diabetes

2. Presence of renal insufficiency or pulmonary disease

3. Presence of clinically significant neuropathy that is clearly of non-diabetic origin

4. Amputations of lower extremities or presence of foot ulcers

5. Major macrovascular events such as myocardial infarction or stroke within the past 3 months

6. Uncontrolled or untreated hypothyroidism

7. Abnormalities of liver function defined as any liver enzymes (AST, ALT, SGPT, SGOT) greater than 3 times the upper limit of normal

8. Other serious medical conditions which, in the opinion of the investigator, would compromise the subject's participation in the study

9. Stable use (> 3 months) of antioxidant supplements or drugs known to affect oxidative stress and PDN

10. Allergy to oxybutynin or other ingredients in Gelnique 3%

11. Pregnancy or breastfeeding

13) History of alcohol abuse in the last year 14) Urinary retention or an enlarged prostate 15) Uncontrolled glaucoma 16) Gastric retention or gastroparesis (hard to digest food) 17) Currently taking other medicines to treat overactive bladder (Anticholinergics)