Cisapride versus placebo for 8 weeks on glycemic control and gastric emptying in insulin-dependent diabetes: A double blind cross-over trial

In insulin-dependent diabetes mellitus, slow gastric emptying may make abso rption unpredictable and foster glycemic instability. Cisa-pride accelerate s emptying, but controlled long term studies are scarce, and effects on gly cemic control unknown. We investigated, in patients with insulin-dependent diabetes mellitus and unstable glycemia, the effects of 10 mg cisapride 4 t imes daily for 8 weeks us. placebo on glycemic control and gastric emptying under random, cross-over, double blind conditions. In 14 patients with del ayed and 9 with nondelayed emptying, blood glucose variability over 2 8-wee k treatment periods separated by a 4-week wash-out and gastric emptying of a semisolid 1168-kJ meal immediately after the treatment periods were asses sed. Cisapride did not affect glycemic control [SD of within-patient mean b lood glucose, 4.2 mmol/L +/- 0.1 (+/-SEM) vs. 4.0 +/- 0.1 mmol/L after plac ebo; hemoglobin A(1c), 8.3 +/- 0.2% vs. 8.5 +/- 0.2%]. Emptying was faster after cisapride than after placebo in 8 of 14 patients with delayed vs. 7 o f 9 with nondelayed emptying (P = NS) and in 11 of 15 without vs. 4 of 8 wi th cardiovascular autonomic neuropathy (P = NS). Autonomic neuropathy preva iled in 7 of 14 patients with delayed and 1 of 9 with nondelayed emptying. Blood glucose immediately before and during assessment of emptying was unre lated to the emptying rate, whereas blood glucose increases over fasting le vels were greater with faster emptying (P < 0.002). In conclusion, cisaprid e's effects were not different from those of placebo on glycemic control an d gastric emptying, it did not differently affect patients with delayed vs. nondelayed emptying, and it slightly accelerated emptying (P = NS) in pati ents without, but not in those with, cardiovascular autonomic neuropathy. B lood glucose levels before and during assessment of emptying did not affect emptying, but the glucose rise over fasting levels was greater with faster emptying.