title: Oral insulin supplementation in paediatric short bowel disease: a pilot observational study.
abstract: OBJECTIVE
  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.
authors.affiliation: Institute for Gastroenterology, Nutrition and Liver Disease, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel-Aviv University, Israel. shamirraanan@gmail.com
authors.forename: Raanan
authors.initials: R
authors.lastname: Shamir
authors.forename: Sanja
authors.initials: S
authors.lastname: Kolacek
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Irit
authors.initials: I
authors.lastname: Tavori
authors.forename: David
authors.initials: D
authors.lastname: Bader
authors.forename: Ita
authors.initials: I
authors.lastname: Litmanovitz
authors.forename: Orna
authors.initials: O
authors.lastname: Flidel-Rimon
authors.forename: Kyla Anna
authors.initials: KA
authors.lastname: Marks
authors.forename: Igor
authors.initials: I
authors.lastname: Sukhotnik
authors.forename: Naim
authors.initials: N
authors.lastname: Shehadeh
mesh_terms: D000284:Administration, Oral; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D007223:Infant; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D019370:Observation; D010288:Parenteral Nutrition; D010865:Pilot Projects; D012778:Short Bowel Syndrome / Q000097:blood / Q000188:drug therapy*; D000637:Transaminases / Q000097:blood; D014280:Triglycerides / Q000097:blood
chemical_list: D007328:Insulin; D014280:Triglycerides; D002784:Cholesterol; D000637:Transaminases