Shin, Andrea

AbstractBackgroundNon‐invasive single photon emission computed tomography (SPECT) has been validated as a test for postprandial gastric volume accommodation, with volumes measured twice over 30 min and averaged. The purpose of this study is to simplify the SPECT measurement of gastric accommodation.MethodsThe primary aim of this study was to compare two postprandial gastric volume measurements with data collected retrospectively from 443 patients and healthy volunteers who had undergone SPECT in the last decade. The differences in the two gastric volumes were compared in the entire group and each subgroup, and the correlation between the two measurements and their differences across a wide range of gastric volumes were plotted.Key ResultsThere was a median difference of <2% (P = 0.041) between postprandial scan 1 (757 mL) and scan 2 (743 mL), with significant correlation (rs = 0.859, P < 0.01) and excellent agreement (SD 60 mL) between the two scans across the entire range of observed postprandial gastric volumes.Conclusions & InferencesA single postprandial scan can detect gastric accommodation with the same accuracy as averaging two postprandial scans. These data support simplifying SPECT measurement of postprandial gastric volume with a scan in the first 15 min after a meal.

OBJECTIVE To investigate the pharmacokinetics (PK), pharmacodynamics, and safety of single-dose RM-131 in type 2 diabetic patients with gastrointestinal cardinal symptoms (GCSI) and previously documented delayed gastric emptying (DGE). RESEARCH DESIGN AND METHODS In a randomized crossover study, 10 female patients received RM-131 (100 μg s.c.) or placebo and underwent scintigraphic gastric emptying (GE) and colonic filling at 6 h (CF6) of a solid-liquid meal administered 30 min postdosing. Adverse events, plasma glucose, and hormonal levels were assessed. GCSI daily diary (GCSI-DD) was completed during treatments. PK was assessed in this cohort and healthy volunteers (HVs). RESULTS At screening, HbA1c was 7.2 ± 0.4% (SEM) and total GCSI-DD score was 1.32 ± 0.21. RM-131 accelerated GE t1/2 of solids (P = 0.011); mean difference (Δ) in solid GE t1/2 was 68.3 min (95% CI 20–117) or 66.1%. There were numerical differences in GE lag time, CF6 solids, and GE t1/2 liquids (all P &lt; 0.14). With a significant (P &lt; 0.014) order effect, further analysis of the first treatment period (n = 5 per group) confirmed significant RM-131 effects on GE t1/2 (solids, P = 0.016; liquids, P = 0.024; CF6, P = 0.013). PK was similar in DGE patients and HVs. There were increases in 120-min blood glucose (P = 0.07) as well as 30–90-min area under the curve (AUC) levels of growth hormone, cortisol, and prolactin (all P &lt; 0.02) with single-dose RM-131. Only light-headedness was reported more on RM-131. CONCLUSIONS RM-131 greatly accelerates the GE of solids in patients with type 2 diabetes and documented DGE. PK is similar in diabetic patients and HVs.