| Eligibility |
Inclusion Criteria:
- Willing and able to provide written, signed informed consent after the nature of the
study has been explained, and prior to any research-related procedures.
- Age is > or = 18 and < or = 49 years (older)
- Obese defined as body mass index > or = 30 kg/m2
- Prediabetic defined as fasting blood glucose 100-126 mg/dl, blood glucose between
140-199 mg/dl at 120 min of oral glucose tolerance test
- healthy, as determined by health history questionnaire, medical history and
physical examination by physician or nurse practitioner, blood chemistries,
resting blood pressure and exercise 12-lead ECG
- blood chemistries indicative of normal renal function (creatinine <2.2 mg/dl),
liver (<3 times upper limit for ALT, AST), and thyroid function (TSH between 0.4
- 5.0 mU/L)
- If currently receiving treatment with or taking any of the following supplements,
be willing and able to discontinue taking them for 2 weeks prior and throughout
the treatment period: Vitamin C, E or other multivitamins containing vitamin C or
E; nutraceuticals containing vitamin C or E
- No history of cardiovascular disease (e.g., heart attack, stroke, heart failure,
valvular heart disease, cardiomyopathy), Type 1 or 2 diabetes mellitus, or
peripheral arterial disease
- Sedentary or recreationally active defined as performs regular aerobic exercise
(30 min or more of vigorous walking, jogging, swimming, cycling, etc) less than 2
days/week or less than 12 days/month over the last year
- Non-smokers, defined as no history of smoking, no smoking for at least the past 1
year
- Normal resting 12-lead ECG.
Exclusion Criteria:
- History of cardiovascular disease such as myocardial infarction, stroke, heart failure
with or without LV ejection fraction <40%, cardiomyopathy, valvular heart disease,
cardiomyopathy, heart transplantation, Type 2 diabetes and Type 1 diabetes
- Smoking or history of smoking within past one year
- History of gastric ulcers, bleeding disorders, dyspepsia, severe gastroesophageal
reflux disease (GERD), or metabolic acidosis
- History of asthma or lung disease (chronic obstructive pulomonary disease, COPD)
- Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left
ventricular hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block,
atrial fibrillation/flutter)
- Serious neurologic disorders including seizures
- History of renal failure, dialysis or kidney transplant
- Serum creatinine > 2.2 mg/dL, or hepatic enzyme concentrations > 3 times the
upper limit of normal
- History of HIV infection, hepatic cirrhosis, other preexisting liver disease, or
positive HIV, Hepatitis B or C test at screening.
- Use of any investigational product or investigational medical device within 30
days prior to screening, or requirement for any investigational agent prior to
completion of all scheduled study assessments.
- History of recent chicken pox, shingles or influenza (ie., risk of Reye's
syndrome) Recent flu-like symptoms within the past 2 weeks
- Pregnant or breastfeeding at screening, or planning to become pregnant (self or
partner) at any time during the study. A urinary pregnancy test will be done on
all females. If test is positive, the subject will be excluded.
- Women with history of hormone replacement therapy within the past 6 months
- History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis,
and Wegener's granulomatosis;
- Taking medications for diabetes mellitus, kidney disease, liver disease, asthma,
sepsis or seizure disorders;
- Taking lipid lowering (e.g., statins, niacin), glycemic control (e.g. metformin,
insulin), anticoagulation, anti-seizure, anti-depression or antipsychotic agents
- History of co-morbid condition that would limit life expectancy to < 6 months.
- It is unknown if Salsalate is transferred in seminal fluid of men. However, it is
recommended that proper protection such as a condom be used during intercourse
during the study.
- Concomitant treatment with: aspirin, baby aspirin, indomethacin, naproxen
(Aleve), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), any other
non-steroidal anti-inflammatory drugs; cox-2 inhibitors (Celebrex, Vioxx, etc);
allopurinol (Zyloprim, Lopurin, Alopurin; coumadin (Wafarin), enoxaparin
(Lovenox); clopidogrel (Plavix); dypyridamole (Persantine); heparin; diabetic
medications (Metformin, glyburide, insulin, etc), TZDs (Avandia, Rezulin, Actos);
corticosteroids (prednisone); methotrexate, infliximib (Remicade), etaneracept
(Enbrel); levothyroxine (Levoxyl, Synthroid, Levoxyl, Unithroid); Levodopa;
Phosphodiesterase (PDE) 5 inhibitors (e.g., Viagra®, Cialis®, Levitra®, or
Revatio®); PDE 3 inhibitors (e.g., cilostazol, milrinone, or vesnarinone);
lithium
- May participate if use of the following medications are discontinued 2 weeks
prior to participation: salicylate medications, aspirin, antioxidants, herbal
supplements, vitamins, omega-3 fatty acids; cox-2 inhibitors (Celebrex, Vioxx,
etc)
- May participate if no use of the following medications in the 48 hours prior to
experimental visits: naproxen (Aleve), acetaminophen (Tylenol), ibuprofen (Advil,
Motrin), other any non-steroidal anti-inflammatory drugs
- Vulnerable populations (prisoners, etc.) are not included in this study because
we are studying healthy middle-aged/older adults.
- Any condition that, in the view of the PI, places the subject at high risk of
poor treatment compliance or of not completing the study.
- Hemoglobin <12 mg/dl for men; < 10 mg/dl for women
- History of alcohol abuse or >10 alcoholic units per week (1 unit= 1 beer, 1 glass
of wine, 1 mixed cocktail containing 1 oz alcohol)
- Low platelets (<100,000 cu mm)
- On weight loss drugs (e.g., Xenical (orilistat), Meridia (sibutramine), Acutrim
(phenylpropanol-amine), or similar over-the-counter medications) within 3 months
of screening
- Any surgery within 30 days of screening
|
