Comprehensive assessment of gastric emptying with a stable isotope breath test

Abstract

Background The [13C]-Spirulina platensis gastric emptying breath test (GEBT) with 5 samples is accurate relative to scintigraphy. This study was primarily designed to further validate this GEBT using a slightly different process for incorporating [13C] in Spirulina and to evaluate the utility of additional samples for assessing early gastric emptying. Methods After a 223 kcal test meal labeled with 99mTc and [13C]-Spirulina platensis, scintigraphic images and 5 breath samples (45, 90, 120, 180, and 240 minutes, GEBT5) were collected in 14 controls (Part A). In Part B, 9 breath samples were collected at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes (GEBT9) in 30 subjects (15 controls, 15 dyspepsia). Using correlation between [13C] breath excretion and scintigraphic emptying, lag time (t10, time for 10% emptying), emptying at 30 min (GE30), and half time (t50) were estimated for GEBT5 (Parts A and B) and GEBT9 (Part B). Key Results t50 values for scintigraphy, GEBT5, and GEBT9 were highly concordant. t10 by GEBT9 (90% CI, 6–15 minutes) was more strongly correlated (CCC 0.80 [95% CI, 0.63–0.90]) with scintigraphy (90% CI, 5–12 minutes), than GEBT5 (10–19 minutes, CCC 0.73 [95% CI, 0.54–0.85]). The correlation between estimated values (GEBT9) and linearly interpolated values (GEBT5) was closer at 60 (CCC 0.95 [95% CI, 0.91–0.97]) than 30 minutes (CCC 0.81 [95% CI, 0.71–0.89]). Conclusions & Inferences The [13C]-Spirulina platensis GEBT can accurately measure GE. While 5 and 9 samples are equally accurate for measuring t50, GEBT9 provides a more comprehensive assessment of early GE (t10 and GE30).

Delayed Gastric Emptying Is Associated With Early and Long-term Hyperglycemia in Type 1 Diabetes Mellitus

“…The GEBT has been extensively used and validated against scintigraphy in health and disease, including in participants with DM. 24, 25 The intra- and inter-individual variability are comparable to that for scintigraphy. 25 In addition, this GEBT has been used in over 2000 patients in Phase I and Phase II pharmaceutical investigations of pro-kinetic drugs under sponsors’ IND exemptions (personal communication, AB Diagnostics), some of which have been published.…”

“…28 The 13C excretion was used to estimate GE T ½ using validated models derived from studies in which GE was simultaneously assessed by the 13C-Spirulina platensis breath test and scintigraphy. 24, 25 For the meal employed, the 10th–90th percentile range for GE T ½ in healthy subjects is 50–92 minutes. 25 Hence, values less than 50 and greater than 92 minutes reflect rapid and delayed GE, respectively.…”

Relationship Between Glycemic Control and Gastric Emptying in Poorly Controlled Type 2 Diabetes

“…These units were used to estimate GE t half using validated models derived from studies in which GE was simultaneously assessed by the 13 C- Spirulina platensis breath test and scintigraphy. 20, 21 For this meal, the 10 th –90 th percentile range for GE t half in healthy subjects is 50–97 minutes. 20 …”

“…20, 21 For this meal, the 10 th –90 th percentile range for GE t half in healthy subjects is 50–97 minutes. 20 …”

Epidemiology and Natural History of Gastroparesis

“…Gastric emptying breath tests utilize 13 C, which is a stable isotope, and offer an alternative approach for measuring solid phase GE without elaborate detection equipment or radiation exposure in the office or bedside. 12, 13 The Food and Drug Administration is currently reviewing a 13 C-spirulina GEBT for use in the United States. Gastric emptying can also be measured by a nondigestible capsule, SmartPill ™ , which records luminal pH, temperature, and pressure during GI transit providing a measure of GE time.…”