Glycaemic control in type II diabetic tube-fed patients with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids: a randomised controlled trial

Objectives: To investigate the effects of long-term treatment with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), in comparison with a standard formula, on glycaemic control in tube-fed type II diabetic patients. Design: Randomised, double-blind, controlled, multi-centre trial. Setting: Early rehabilitation centres, primary care and nursing facilities. Subjects: A total of 78 patients with insulin-treated type II diabetes with HbA(1C) >= 7.0% and/or fasting blood glucose 46.66 mmol/l, who required enteral tube feeding due to neurological dysphagia. Interventions: Patients received 113 kJ ( 27 kcal)/kg of body weight of either test feed or an isoenergetic, isonitrogenous enteral formula ( control) for 12 weeks. Glycaemic control ( total daily insulin dosage (IU), fasting blood glucose, and HbA(1C)) and gastrointestinal tolerance were monitored daily. Results: After 12 weeks, median values for changes from baseline were as follows ( test group vs control group, 'data as available' analysis): total daily IUs - 6.0 vs 0.0 ( P = 0.0024), fasting blood glucose ( mmol/l) -1.59 vs - 0.08 ( P = 0.0068); HbA(1C) (%) - 0.8 vs 0.0 ( P = 0.0016). Both formulas were tolerated comparably. Conclusions: This study indicates that in tube-fed insulin-treated type II diabetic patients, the new low-carbohydrate, high MUFA formula results in a more effective glycaemic control than the standard diet, while being comparable in safety.