Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03050827
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03050827
Study Brief:
Protocol Section:
NCT03050827