Pohl M, Mayr P, Mertl-Roetzer M, Lauster F, Lerch M, Eriksen J, Haslbeck M, Rahlfs V W
Department of Early Neurological Rehabilitation, Klinik Bavaria, Kreischa, Germany.
Eur J Clin Nutr. 2005 Nov;59(11):1221-32. doi: 10.1038/sj.ejcn.1602232.
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.
Randomised, double-blind, controlled, multi-centre trial.
Early rehabilitation centres, primary care and nursing facilities.
A 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.
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.
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.
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.
与标准配方相比，研究长期使用一种碳水化合物含量低、单不饱和脂肪酸（MUFAs）含量高的新型肠内配方对管饲II型糖尿病患者血糖控制的影响。
随机、双盲、对照、多中心试验。
早期康复中心、初级保健机构和护理机构。
共有78例接受胰岛素治疗的II型糖尿病患者，其糖化血红蛋白（HbA1C）≥7.0%和/或空腹血糖>6.66 mmol/l，因神经源性吞咽困难需要肠内管饲。
患者接受113 kJ（27 kcal）/kg体重的试验性饲料或等能量、等氮的肠内配方（对照），持续12周。每天监测血糖控制情况（每日胰岛素总剂量（IU）、空腹血糖和HbA1C）以及胃肠道耐受性。
12周后，与基线相比的变化中位数如下（试验组与对照组，“现有数据”分析）：每日胰岛素总剂量-6.0 vs 0.0（P=0.0024），空腹血糖（mmol/l）-1.59 vs -0.08（P=0.0068）；HbA1C（%）-0.8 vs 0.0（P=0.0016）。两种配方的耐受性相当。
本研究表明，对于管饲胰岛素治疗的II型糖尿病患者，新型低碳水化合物、高MUFA配方在血糖控制方面比标准饮食更有效，且安全性相当。
