Endocrine Research

Investigator: William A. Bauman, MD.

 

After SCI, adverse changes occur in soft tissue body composition, which are associated with disorders of carbohydrate (e.g., sugar) and cholesterol metabolism. These disorders in metabolism predispose to microvascular dysfunction and cardiovascular disease. Strategies are being considered to reduce insulin resistance and improve insulin release after SCI. The higher prevalence of insulin-resistant states in the SCI population may adversely influence neural modulation of the tone of smaller vessels, which may have deleterious effects on carbohydrate metabolism and the development and/or healing of pressure ulcers. Cardiovascular disease is recognized as a major cause of illness and death in those with SCI. If those with increased cardiovascular risk can be more accurately identified, which is being accomplished by noninvasive means, then appropriate treatment may be instituted to lower the chance of having a heart attack. Our investigators are working to prevent bone loss of the paralyzed legs shortly after SCI or to reverse the bone loss in those with long-standing SCI with medications and/or by mechanical means (e.g., treatments to prevent osteoporosis). If our efforts are successful in improving bone mass and strength, then fractures that occur to the legs after minor trauma can be reduced or prevented.


Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons with SCI
Visit 1: A family history questionnaire, an oral glucose test, blood draw, body composition measurements, and 24-hour heart rate monitoring will be performed.
Visit 2: A computed tomography test (CT) scan will be performed on your heart to determine the amount of plaque that is in your arteries.
Visit 3 (Optional): We will ask you to drink a high fat milkshake, and perform serial blood draws.
Entry Criteria: Males, 40-75 years old, with chronic (=5 years) SCI; Females, 50-75 years old, with chronic (=10 years) SCI; no acute illness; no chronic debilitating disease (stage IV pressure ulcers, severe pulmonary disease,etc).
Time Commitment: Day 1: 4 hours; Day 2: 2 hours
Reimbursement: $150/visits 1 and 2


The Efficacy of Denosumab to Reduce Osteoporosis after Acute Spinal Cord Injury
Visit 1 (Baseline/Month 0): Dual Energy X-Ray Absorptiometry (DXA), Bio-impedance spectroscopy (BIS) and Peripheral quantitative computed tomography (pQCT) scans will be performed to measure calcium levels and bone density and structure; your blood will be drawn to measure calcium and vitamin D levels; a 24-hour urine collection will be performed; and you will receive an injection of either denomsumb or a placebo in your arm
Visit 2 (Month 1): DXA, BIS, and pQCT scans will be performed; your blood will be drawn; and a 24-hour urine collection will be performed
Visit 3 (Month 3): DXA and BIS scans will be performed, your blood will be drawn, and a 24-hour urine collection will be performed
Visit 4 (Month 6): DXA, BIS, and pQCT scans will be performed; your blood will be drawn; a 24-hour urine collection will be performed; and you will receive an injection of either denomsumb or a placebo in your arm
Visit 5 (Month 9): Your blood will be drawn
Visit 6 (Month 12): DXA, BIS, and pQCT scans will be performed; your blood will be drawn; a 24-hour urine collection will be performed; and you will receive an injection of either denomsumb or a placebo in your arm
Visit 7 (Month 18): DXA and BIS scans will be performed, your blood will be drawn, and a 24-hour urine collection will be performed
Entry Criteria: Males ages 18-65 or females 18-50 with acute, motor-complete (AIS A and B) SCI (<1 year), no extensive life-threatening injury in addition to SCI, no heterotopic ossification or other bone diseases, no acute fracture or extensive bone trauma, no prior anabolic steroid hormonal therapy (including corticosteroids), no prior or current diagnosis of cancer, no chronic alcohol abuse, no hypocalcemia, no hyperthyroidism, no Cushing’s disease, no existing dental conditions, or other chronic diseases; WOMEN: also must not post-menopausal or pregnant; MEN: also must not have had hypogonadism prior to SCI
Time Commitment: 7 visits, each 1 hour, over the course of 18 months
Reimbursement: $500/visits 1-7


An Open Label Safety and Efficacy Trial of Fenofibrate in Persons with SCI
Visit 1 (Screening): Your blood will be drawn to determine if your triglyceride levels are high enough to qualify for study participation
Visit 2(Baseline): Your blood will be drawn to confirm your triglyceride levels are high enough for study participation, a Dual Energy X-Ray Absorptiometry (DXA) scan will be performed, you will receive dietetic counseling to learn more about your food choices and calorie consumption, and you be assigned to one of two group: treatment, which receives a daily dose of Fenofibrate, or no treatment
Visit 3 (Month 1): Your blood will be drawn to determine if Fenofibrate has an effect on your triglyceride levels
Visit 4 (Month 2): Your blood will be drawn and you will receive dietetic counseling
Visit 5 (Month 3): Your blood will be drawn
Visit 6 (Month 4): Your blood will be drawn and a DXA scan will be performed if changes to your body fat levels have occurred
Visit 7 (Post 1-month): Your blood will be drawn
Entry Criteria: Ages 21-69 with chronic SCI (>1 year); ASIA A, B or C; no acute illness; no reduced kidney function; no atherosclerosis, congestive heart failure, or other heart problems; no diabetes; no hypersensitivity to Fenofibrate; not currently taking medications known to affect triglyceride concentrations; WOMEN: also not pregnant
Time Commitment: 7 visits, each 30-45 minutes, over the course of 4 months
Reimbursement: $450/visits 1-7


Precision of Body Composition Measurements in Persons with Spinal Cord Injury
A Dual Energy X-Ray Absorptiometry (DXA) scan will be performed twice on your whole body to determine the amount of muscle and bone in your lower extremities.
A bio-impedance spectroscopy (BIS) will be performed twice on your arms and legs to determine the amount of fat and water. This will be done using a small, electric current that flows through leads attached to your hands and feet.
A soft measuring tape will be used to measure the size and lengths of different body parts
Entry Criteria: Individuals ages 18-65 with chronic SCI, no heterotopic ossification or other bone diseases, no hip or knee replacements or metal hardware in lower extremities, no acute or chronic illness, no severe contractures, or other medical complications; or healthy able-bodied individuals
Time Commitment: One 1-hour visit
Reimbursement: $25


Glucagon-like Peptide: Testing its Safety and Efficacy in Disorders of Carbohydrate Metabolism in Patients with Chronic SCI
You will be one of 30 subjects enrolled in a 26 week (7 month) treatment to improve metabolism and body composition.
Visit 1 (Screening): Blood draws and oral glucose tolerance test will be performed.
Visit 2 (Baseline): Blood draws, oral glucose tolerance test, and body composition analysis will be performed.
Visit 3 (Week 6): Blood draws will be performed.
Visit 4 (Week 13): Blood draws, oral glucose tolerance test, and body composition analysis will be performed.
Visit 5 (Week 19): Blood draws will be performed.
Visit 6 (Week 26): Blood draws, oral glucose tolerance test, and body composition analysis will be performed.
Entry Criteria: Age 18-69, chronic SCI greater than 1 year, BMI greater than 23 kg/m², non-diabetic.
Time Commitment: 26 weeks (7 months), 6 total visits
Reimbursement: Pending


NOT YET RECRUITING:
  • Glucagon-like Peptide: Testing its Safety and Efficacy in Disorders of Carbohydrate Metabolism in Patients with Chronic SCI
  • The Efficacy of Ibandronic Acid (Denosumab) to Prevent Bone Loss in Ambulatory Patients with Acute Spinal Cord Injury (Motor Incomplete Injuries)

Studies Underway

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Contact Us

Joshua Hobson, MS, CBDT
Research Coordinator
JJP VAMC, Bronx N.Y.

(718) 584-9000 ext. 3129
Joshua.Hobson@va.gov

Christopher M. Cirnigliaro, MS, CES, CBDT
Senior Research Coordinator
Kessler Institute for Rehabilitation

1199 Pleasant Valley Way
West Orange, NJ 07052
Tel: (973) 731-3900 x2755
Fax: (973) 243-6892