Status:
COMPLETED
Pilot Study to Determine Effects of Salsalate in Type 1 Diabetes and Painful Peripheral Neuropathy
Lead Sponsor:
University of Michigan
Conditions:
Peripheral Neuropathy
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This 12 week study will examine the effects of daily Salsalate treatment on markers of neuropathic pain and intra-epidermal nerve fiber density. the study is being done in people with type 1 diabetes ...
Detailed Description
This project will be used to establish preliminary data for a planned NIH-sponsored multicenter study of the effects of salsalate on diabetic neuropathy (DN) in people with type 1 diabetes. Diabetic p...
Eligibility Criteria
Inclusion
- Type 1 diabetes (T1D)
- Peripheral neuropathy with symptoms of pain, or with other uncomfortable symptoms (e.g., burning, prickling).
- 18 to 70 years old
- Stable insulin treatment program for at least the past 3 months.
- Abnormal nerve conduction studies (based on study screening examination)
- Willing and able to take an oral (by mouth) medication 3 times per day for 3 months.
- WOMEN using an appropriate method of contraception during the course of the study (hormonal, IUD, or diaphragm.
- Willing and able to provide written informed consent for study participation.
Exclusion
- Neuropathy from a cause other than diabetes.
- Allergy to salsalate or similar medications (aspirin, non-steroidal anti-inflammatory medicines like ibuprofen and naproxen).
- Currently on blood thinning agents such as Coumadin, Heparin, Plavix, Pradaxa, high-dose aspirin (more than 325 mg daily).
- Any severe low blood sugar episodes in the past 6 months (needed assistance to treat).
- Diabetic ketoacidosis in the past 6 months.
- Severe neuropathy, or have had an ulcer or amputation on either foot or either leg.
- Creatinine level (a measure of kidney function is greater than 1.4 mg/dl (for women) or greater than 1.5 mg/dl (for men) or your estimated GFR is under 60.
- Albumin in your urine or other signs of reduced kidney function.
- Liver enzymes (including ALT, AST and Bilirubin) levels are more than 2 and ½ times the upper limit of normal.
- Blood platelets are less than 100,000 at the time of screening.
- Organ transplant (lung, kidney, heart, pancreas, liver).
- Chronic immunosuppressive therapy, for example, daily prednisone or other steroids, methotrexate, Imuran, CellCept. This includes daily, or recurrent use of oral steroids used to treat asthma.
- Regular NSAID medications (e.g., Naproxen, Ibuprofen) use. If used occasionally, you will be asked to not use them during the study.
- History of drug or alcohol abuse, or if you take more than 10 alcoholic drinks per week.
- History of stomach ulcers or bleeding from your bowel.
- Heart attack, heart bypass surgery, heart failure or a stroke EVER.
- Current treatment for any cancer (other than basal cell or squamous cell skin cancer).
- Treatment with lithium.
- Ever had Reyes' syndrome.
- Pregnant, nursing, or planning to become pregnant during the time of the study.
- Allergic to lidocaine or epinephrine (used for numbing skin prior to biopsies).
- Keloid scarring in the past.
- Receiving other experimental treatments.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01480297
Start Date
November 1 2011
End Date
September 1 2014
Last Update
April 24 2015
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109