Effect of itopride on gastric emptying in longstanding diabetes mellitus

Delayed gastric emptying (GE) occurs in 30-50% of patients with longstanding type 1 or 2 diabetes, and represents a major cause of morbidity. Current therapeutic options are limited. We aimed at evaluating the effects of itopride on GE in patients with longstanding diabetes. Twenty-five patients (20 type 1, 5 type 2; 10 males, 15 females; mean age 45.2 +/- 2.7 years; body mass index 27.5 +/- 0.9 kg m(-2); duration of diabetes 20.2 +/- 2.4 years) were enrolled in a double-blind, placebo-controlled, randomized, crossover trial. Subjects received both itopride (200 mg) and placebo t.i.d. for 7 days, with a washout of 7-14 days. GE (scintigraphy), blood glucose (glucometer) and upper gastrointestinal (GI) symptoms (questionnaire) were measured following each treatment period. The test meal comprised 100 g ground beef (99mTc-sulphur colloid) and 150 mL of 10% dextrose [67Ga-ethylenediaminetetraacetic acid (EDTA)]. There was a slight trend for itopride to accelerate both solid (P = 0.09) and liquid (P = 0.09) GE. With itopride treatment, the emptying of both solids and liquids tended to be more accelerated, as the emptying with placebo was slower (solids: r = 0.39, P = 0.057; liquids: r = 0.44, P < 0.03). Twelve (48%) patients had delayed solid and/or liquid GE on placebo and in this group, itopride modestly accelerated liquid (P < 0.05), but not solid (P = 0.39), emptying. Itopride had no effect on mean blood glucose during the GE measurement (placebo: 9.8 +/- 0.6 mmol L(-1) vs itopride: 9.6 +/-0.6 mmol L(-1)), or GI symptoms (placebo: 1.4 +/- 0.4 vs itopride: 1.8 +/- 0.5). Itopride, in a dose of 200 mg t.i.d. for 7 days, tends to accelerate GE of liquids and solids in longstanding diabetes. The magnitude of this effect appears to be modest and possibly dependent on the rate of GE without itopride.