Marinella Galea

SmartPill technology provides safe and effective assessment of gastrointestinal function in persons with spinal cord injury

Study design:Spinal cord injury (SCI) results in gastrointestinal (GI) complications, including gastroesophageal reflux disease and constipation, but much of the data is based on older technology.Objective:GI transit times were determined in subjects with SCI using a new device called a SmartPill. Our principal goal was to assess whether this new technology can be applied in persons with SCI.Methods:SCI and age- and gender-matched able-bodied (AB) control subjects not taking proton pump inhibitors were studied. Following an 8-h overnight fast, subjects consumed 120 g EggBeaters (60 kcal), two slices of white bread (120 kcal) and 30 g strawberry jam (74 kcal). A pH calibrated SmartPill capsule was swallowed with 8 ounces of water, after which subjects fasted for an additional 6 h prior to consuming an Ensure Plus nutrition shake (350 kcal). Subjects remained fasted for an additional 2 h, after which time they resumed their regular diets.Results:Twenty subjects with SCI and 10 AB control subjects were studied. Data are expressed as mean±s.d. Comparing the group with SCI to the AB control group, gastric emptying time (GET), colonic transit time (CTT) and whole gut transit time (WGTT) were prolonged (GET: 10.6±7.2 vs 3.5±1.0 h, P<0.01; CTT: 52.3±42.9 vs 14.2±7.6 h, P=0.01; WGTT: 3.3±2.5 vs 1.0±0.7 days, P<0.01). No complications or side effects were reported.Conclusion:Our results indicate that the SmartPill technology is a safe, non-invasive assessment technique that provides valid diagnostic information in persons with SCI.

The influence of visceral fat on the postprandial lipemic response in men with paraplegia.

Background: Postprandial lipemia (PPL) is associated with vascular dysfunction and may be an etiologic factor in the progression of atherogenic cardiovascular disease. Objective: In 10 men with paraplegia and 10 able-bodied men, the magnitude of the PPL responses and the relationship of abdominal adiposity and the PPL responses were determined. Methods: Anthropometrics, dual energy x-ray absorptiometry, and abdominal ultrasonography were performed to determine visceral fat and total body fat. A fasting lipid profile was performed. A high-fat milkshake (1.3 g fat/kg body mass) was administered with serum collected at baseline and at 2, 4, and 6 hours after the test meal for subsequent measurement of triglyceride. The triglyceride response was determined by the area under the triglyceride curve. Results: No significant differences were noted between the groups in fasting lipid values or in measures of visceral fat. Total body fat tended to be higher in men with paraplegia than in able-bodied men (34.9 ± 10.0 vs. 27.3 ± 6.7%, p  =  0.07). No significant difference between the groups was observed in triglyceride response. In men with paraplegia, visceral fat was strongly associated with the triglyceride (r  =  0.8, p  =  0.005), fasting low-density lipoprotein (r  =  0.66, p  =  0.04), and triglyceride responses (r  =  0.80, p  =  0.005); a significant relationship was not found between fasting high-density lipoprotein and any measure of adiposity. In men with paraplegia, triglyceride response was positively related to all measures of abdominal adiposity. Conclusion: Visceral abdominal fat was related to delayed triglyceride clearance after a fat load, which may contribute to coronary heart disease (CHD) risk and progression of vascular disease in men with paraplegia.

Clinical trial: the efficacy and safety of routine bowel cleansing agents for elective colonoscopy in persons with spinal cord injury – a randomized prospective single‐blind study

Background  As difficulty with evacuation is a common occurrence in individuals with spinal cord injury, preparation prior to colonoscopy may be suboptimal and, perhaps, more hazardous.

A retrospective chart review of heart rate and blood pressure abnormalities in veterans with spinal cord injury

Abstract Objective Autonomic impairment may lead to increased prevalence of heart rate (HR) and blood pressure (BP) abnormalities in veterans with spinal cord injury (SCI). In addition, comorbid medical conditions and prescription medication use may influence these abnormalities, including bradycardia, and tachycardia, hypotension, hypertension as well as autonomic dysreflexia (AD), and orthostatic hypotension (OH). Design A retrospective review of clinical and administrative datasets in veterans with SCI and compared the prevalence rates between clinical values and ICD-9 diagnostic codes in individuals with tetraplegia (T: C1–C8), high paraplegia (HP: T1–T6), and low paraplegia (LP: T7 and below). Results The prevalence of clinical values indicative of a HR ≥ 80 beats per minute was higher in the HP compared to the LP and T groups. A systolic BP (SBP) ≤ 110 mmHg was more common in the T compared to the HP and LP groups, whereas the prevalence of a SBP ≥ 140 mmHg was increased in the LP compared to the HP and T groups. Diagnosis of hypertension was 39–60% whereas the diagnosis of hypotension was less than 1%. Diagnosis of AD and OH was highest in the T group, but remained below 10%, regardless of categorical lesion level. Antihypertensive medications were commonly prescribed (55%), and patients on these medications were less likely to have high BP. The odds ratio of higher SBP and DBP increased with age and body mass index (BMI). Conclusion In veterans with SCI, the prevalence of HR and BP abnormalities varied depending on level of lesion, age, BMI, and prescription medication use.

A prospective report on the prevalence of heart rate and blood pressure abnormalities in veterans with spinal cord injuries.

Abstract Objective Decentralized autonomic cardiovascular regulation may lead to increased prevalence of heart rate (HR) and blood pressure (BP) abnormalities in veterans with SCI. In addition, comorbid medical conditions and prescription medication use may increase HR and BP abnormalities. These abnormalities include bradycardia, and tachycardia, hypotension, hypertension as well as autonomic dysreflexia and orthostatic hypotension; the prevalence of which is unknown. Design HR and BP data were measured during a routine annual physical examination in 64 veterans with SCI. Measurements of HR and BP were recorded in the seated and supine positions to document the influence of body position and to document intra-subject variability in these assessments. Results All subjects were chronically injured (20 ± 14 years), 33 subjects were tetraplegic (T: C3–C8), nine had high paraplegia (HP: T1–T6), and 22 had low paraplegia (LP: T7–L2). Regardless of position, the prevalence of bradycardia was increased in the T group, whereas prevalence of tachycardia was increased in the HP and LP groups. Systolic hypotension was more common in the T and HP groups than the LP group and positional effects were most evident in the T group. Systolic hypertension was comparable in the T and HP groups but was twice as prevalent in the LP group. Increased prevalence of individuals with three or more medical conditions and prescribed three or more medications which might influence HR and BP was observed. Conclusion Decentralized autonomic regulation, comorbid medical conditions, and prescription medication use in veterans with SCI result in HR and BP abnormalities; our data suggest that these abnormalities vary depending on the level of injury and orthostatic positioning.

Comparison between pulsed irrigation enhanced evacuation and polyethylene glycol-electrolyte lavage solution for bowel preparation prior to elective colonoscopy in veterans with spinal cord injury

Abstract Background Poor preparation for elective colonoscopy is common in persons with spinal cord injury (SCI). This unsatisfactory outcome is likely due to long-standing difficulty with evacuation and decreased colonic motility. Our objective was to determine the most effective preparation for elective colonoscopy applying a novel and traditional approach to bowel cleansing. Methods Twenty-four subjects with SCI were consented and scheduled to receive one of the two possible arms: pulsed irrigation enhanced evacuation (PIEE) or polyethylene glycol-electrolyte lavage solution (PEG; CoLyte®). The quality of the preparation was scored during the colonoscopy by applying the Ottawa scoring system. Results Patients with SCI who received PIEE tended to have lower Ottawa scores and a higher percentage of acceptable preparations than did those who received PEG; however, the results were not statistically different. Conclusion In this preliminary study in subjects with SCI, neither PIEE nor PEG produced acceptable bowel preparation for elective colonoscopy. Future studies should confirm our findings and consider studying alternative, more efficacious approaches to bowel cleansing prior to colonoscopic procedures in patients with SCI, which should provide better outcomes. Registration number for clinicaltrials.gov: NCT00745095.

Prevalence of abnormal systemic hemodynamics in veterans with and without spinal cord injury.

OBJECTIVE Increased prevalence of heart rate and blood pressure abnormalities are evident in persons with spinal cord injury (SCI), but age, comorbid medical conditions, and prescription medication use may contribute. To determine differences in the prevalence of cardiac acceleration (heart rate ≥80 beats per minute), hypotension (blood pressure ≤110/70mmHg), orthostatic hypotension (OH) (-20/-10mmHg with upright positioning), and hypertension (HTN) (blood pressure ≥140/90mmHg) in veterans with and without SCI. DESIGN Observational trial. SETTING Medical center. PARTICIPANTS Subjects included veterans with SCI (n=62; cervical: tetraplegia, C3-8; high thoracic, T1-5; low thoracic, T7-L2) and veterans without SCI (n=160). INTERVENTIONS None. MAIN OUTCOME MEASURES We assessed medical history, prescription medication use, and heart rate and blood pressure during a routine clinical visit. Prevalence rates of cardiac acceleration, hypotension, OH, and HTN were calculated using binary logistic regression analysis with 95% confidence intervals. The influence of SCI status, age, smoking status, cardiovascular diagnoses, and use of prescribed antihypertensive medications on the prevalence of abnormal heart rate and blood pressure recordings was determined. RESULTS The diagnosis of HTN was reduced in the high thoracic and tetraplegia groups compared with the non-SCI and low thoracic groups. Use of antihypertensive medications was increased in the low thoracic group compared with the other 3 groups and was increased in the non-SCI group compared with the tetraplegia group. The prevalence of cardiac acceleration was reduced, and the prevalence of systolic hypotension was increased in the tetraplegia group. The prevalence of diastolic hypotension was increased in all SCI groups compared with the non-SCI group. For all analyses, increased prevalence of abnormal heart rate and blood pressure recordings was not further explained by the covariates, with the exception of age, cardiovascular diagnoses, and antihypertensive medications in the cardiac acceleration model; however, SCI status remained significant and was the dominant predictor variable. CONCLUSIONS Our data suggest that SCI status contributes to the prevalence of cardiac acceleration and systolic and diastolic hypotension regardless of cardiovascular medical conditions or prescription antihypertensive medication use.

Pulse-Irrigation Enhanced Evacuation and MoviPrep® With Adjunctive Neostigmine and Glycopyrrolate Improve Bowel Preparation for Colonoscopy After Spinal Cord Injury

Results: After induction therapy, 31 patients responded and 24 reached clinical remission. At baseline, HBi was 11 (6.5-17.5), partial Mayo score 8.5 (7.5-9), FC 2060 (1495-5507) μg/g and CRP 13 (6.5-35.5) mg/L. Following induction therapy, indices, FC and CRP declined from baseline levels (p 221 μg/g that number was 9 out of 15 (60%) within the same time period. Clinical activity correlated with FC (Spearman r=0.62, p 221 μg/g after the induction period is associated with a disease incident within the following 24 weeks. The indices, FC and CRP levels decreased significantly from baseline levels among patients responding to infliximab treatment.

T1827 Neurogenic Bowel in Persons With Spinal Cord Injury: An Evaluation Using SmartPill® Technology

and small nuclear ribonuclear polypeptide A were present in high titers in serum that contained anti-enteric neuronal antibodies in our neuronal assays. Our Invitrogen®ProtoArray assay did not find these antibodies in serum in which our immunostaining assay found no anti-enteric neuronal antibodies. Moderate levels of anti-ro 52000 MW antibody were present also in IBS serum. Anti-ro 52000 is a known biomarker for Sjogrens syndrome. Conclusion: The gut does not work well when the enteric nervous system (ENS) is not working well. The gut does not work at all without the ENS. The results suggest that symptoms in an unexpectedly large subset of patients with a diagnosis of IBS, might result from a degenerative ENS neuropathy with anti-enteric antibodies serving as a biomarker.

1011 Oral Phosphosoda for Bowel Preparation Before Colonoscopy: Renal Toxicity in Elderly Patients with Diabetes Mellitus

Background: Oral sodium phosphate solution (OSPS) is commonly used for bowel preparation prior to colonoscopy(C). Many studies have established the efficacy of OSPS. However, its safety has not been studied prospectively in elderly patients with diabetes mellitus (DM), a group that may be predisposed to phosphate nephropathy (Markowitz et al, J Am Soc Neph, 2005). Aim: To compare the safety and efficacy of the oral phosphosoda in elderly subjects with and without diabetes mellitus. Methods: Elderly subjects (≥ 70years) undergoing screening colonoscopy (Creatinine (Cr) ≤ 1.3, eGFR ≥ 60 ml/min) received OSPS (Fleet phospho-soda, 45ml x 2) for colon cleansing. Serum creatinine (Cr) mg/dl, eGFR ml/ min, electrolytes and urine N-acetyl-β-D-glucosaminadase (NAG, u/mg) (an enzyme released by the renal tubules in response to injury) were used to assess the safety of the OSPS. Parameters were collected a week before C, on the day of C and a week after C. The quality of the preparation was assessed by the endoscopist using the Ottawa scale (OS) (0=perfect score; 14= poor prep). DM was defined as an HbA1C ≥ 6% and fasting blood glucose ≥ 120 mg/dl. Results: The increase in Cr in elderly diabetics after ingestion of OSPS was significantly different (1.18±0.17 to 1.56±0.37, p<0.03) compared to non diabetics (0.89± 0.08 to 0.91±0.1). One week post C, Cr remained elevated in diabetics compared to nondiabetics (1.33±0.37 vs. 0.85±0.05; p<0.008). The eGFR in elderly diabetic subjects was decreased after administration of OSPS compared to baseline (97.3±4.5 to 65.3±19.05; p<0.05) and remained reduced (66.5±12; p<0.05) one week after C, whereas, the OSPS did not reduce the eGFR in elderly non-diabetic subjects. NAG was significantly elevated after administration of OSPS in diabetics (0.67±0.24 to 1.3±0.25, p<0.01) and continued to be elevated one week after OSPS (1.98±.78, p<0.02) compared to baseline. Urinary NAG in non-diabetics after OSPS was not different than baseline. Serum electrolytes were altered in both diabetics and non-diabetics compared to baseline. All the subjects had endoscopically acceptable preps (OS≤3). The quality of the preparation was not significantly different between diabetic and non diabetic subjects. Conclusion: OSPS is an effective agent for colon cleansing prior to colonoscopy in both diabetic and non-diabetic elderly subjects, but was associated with significant renal impairment in elderly diabetics. The use of OSPS in elderly diabetic patients should be avoided whenever possible, even when baseline renal function is within normal limits.