title: Glycemic control in patients with type 2 diabetes mellitus with a disease-specific enteral formula: stage II of a randomized, controlled multicenter trial.
abstract: BACKGROUND
  Stage I of a preplanned 2-stage study has provided good evidence for improved glycemic control with a disease-specific enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), fish oil, chromium, and antioxidants in insulin-treated type 2 diabetes. The study was continued with stage II to give confirmatory proof of these beneficial effects.
  
  
  METHODS
  105 patients with HbA1C>or=7.0% and/or fasting blood glucose (FG)>6.7 mmol/L (>120 mg/dL) requiring enteral tube feeding due to neurological dysphagia received 113 kJ (27 kcal)/kg body weight of either test formula (Diben) or an isoenergetic, isonitrogenous standard formula (control) for up to 84 days. Total insulin (TI) requirements, FG, and afternoon blood glucose (AG) were assessed daily. HbA1C and safety criteria were evaluated on days 1, 28, 56, and 84.
  
  
  RESULTS
  55 patients completed the study; on day 84, median changes from baseline (data as available, test vs control) were the following: TI, -8.0 vs +2.0 IU; FG, -2.17 vs -0.67 mmol/L (-39.0 vs -12.1 mg/dL); HbA(1C), -1.30% vs -1.20%; AG, -2.36 vs -0.49 mmol/L (-42.5 vs -8.9 mg/dL). The number of relevant hypoglycemic episodes (FG<3.33 mmol/L<60 mg/dL) was 1 vs 5. Feeding tolerance was comparable in both groups.
  
  
  CONCLUSIONS
  Long-term tube feeding with a disease-specific enteral formula was safe and well tolerated in type 2 diabetic patients with neurological disorders. When compared with a standard diet, TI requirement decreased significantly with less hypoglycemia whereas FG and AG were significantly lowered, resulting in improved glycemic control.
authors.affiliation: Department of Early Neurological Rehabilitation, Klinik Bavaria, Kreischa, Germany. marcus.pohl@klinik-bavaria.de
authors.forename: Marcus
authors.initials: M
authors.lastname: Pohl
authors.forename: Peter
authors.initials: P
authors.lastname: Mayr
authors.forename: Marion
authors.initials: M
authors.lastname: Mertl-Roetzer
authors.forename: Frank
authors.initials: F
authors.lastname: Lauster
authors.forename: Manfred
authors.initials: M
authors.lastname: Haslbeck
authors.forename: Beate
authors.initials: B
authors.lastname: Hipper
authors.forename: Diethard
authors.initials: D
authors.lastname: Steube
authors.forename: Monika
authors.initials: M
authors.lastname: Tietjen
authors.forename: Jan
authors.initials: J
authors.lastname: Eriksen
authors.forename: Volker W
authors.initials: VW
authors.lastname: Rahlfs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D008076:Cholesterol, HDL / Q000032:analysis / Q000097:blood; D008078:Cholesterol, LDL / Q000032:analysis / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D050528:Diet, Carbohydrate-Restricted / Q000379:methods; D004311:Double-Blind Method; D004750:Enteral Nutrition / Q000592:standards; D005260:Female; D005526:Food, Formulated / Q000592:standards*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control*; D007328:Insulin / Q000032:analysis / Q000097:blood; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged
chemical_list: D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D007328:Insulin