Oral insulin supplementation in paediatric short bowel disease: a pilot observational study.

BACKGROUND AND AIM: Insulin is present in human milk, and oral insulin supplementation causes a dramatic adaptive gut growth in a rat model of short bowel syndrome (SBS). We conducted an open-label pilot observational study to examine whether oral insulin supplementation to paediatric patients with SBS decreases the need for parenteral nutrition (PN).
METHODS: Between April 2004 and March 2006, 10 premature infants and children were recruited from 8 paediatric gastroenterology centres in Israel, Croatia, and Germany. Enrolled subjects received 1 unit of insulin (Actrapid, Novonordisk, Denmark)/kg body weight per dose x 4/day (every 6 hours) for 28 days. We monitored glucose blood levels, weight, enteral and parenteral intake of calories, carbohydrates, and lipids. In addition, blood levels of albumin, ALT, AST, GGT, ALP, total cholesterol, triglycerides, and anti-insulin antibodies were recorded.
RESULTS: On average, enteral intake increased from 45.6% +/- 30.6% to 58.9% +/- 28.2% (not statistically significant), and ALT blood levels decreased from 194 +/- 128 U to 136 +/- 79 U (not statistically significant). Two (2/10) infants were weaned off PN. None of the children developed insulin antibodies.
CONCLUSIONS: Oral insulin supplementation in paediatric SBS is not associated with short-term side effects. Although clinical improvement was observed in a subset of children, whether these effects are due to insulin administration is uncertain. The efficacy of oral insulin remains to be determined in a double-blind manner using a preparation that is resistant to degradation in the stomach.