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Randomized Controlled Trial Multicenter Study Comparative Study
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.
- M Pohl, P Mayr, M Mertl-Roetzer, F Lauster, M Lerch, J Eriksen, M Haslbeck, and V W Rahlfs.
- Department of Early Neurological Rehabilitation, Klinik Bavaria, Kreischa, Germany. marcus.pohl@klinik-bavaria.de
- Eur J Clin Nutr. 2005 Nov 1;59(11):1221-32.
ObjectivesTo 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.DesignRandomised, double-blind, controlled, multi-centre trial.SettingEarly rehabilitation centres, primary care and nursing facilities.SubjectsA total of 78 patients with insulin-treated type II diabetes with HbA(1C) > or =7.0% and/or fasting blood glucose >6.66 mmol/l, who required enteral tube feeding due to neurological dysphagia.InterventionsPatients 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.ResultsAfter 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.ConclusionsThis 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.
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