Pilot Study to Determine Effects of Salsalate in Type 1 Diabetes and Painful Peripheral Neuropathy
Condition: Peripheral Neuropathy; Type 1 Diabetes
MeSH terms: Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Salsalate
Intervention description: Salsalate 3 grams daily (1 gram TID with meals)
Intervention MeSH terms: Salicylsalicylic acid; Sodium Salicylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pain; Neuropathy; Diabetes type 1

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 with signs and symptoms of peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.