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.
OBJECTIVE
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.


METHODS
Randomised, double-blind, controlled, multi-centre trial.


METHODS
Early rehabilitation centres, primary care and nursing facilities.


METHODS
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.


METHODS
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.
Pohl
M
M
Department of Early Neurological Rehabilitation, Klinik Bavaria, Kreischa, Germany. marcus.pohl@klinik-bavaria.de
Mayr
P
P
Mertl-Roetzer
M
M
Lauster
F
F
Lerch
M
M
Eriksen
J
J
Haslbeck
M
M
Rahlfs
V W
VW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy*; D050528:Diet, Carbohydrate-Restricted / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D004750:Enteral Nutrition / Q000379:methods*; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects; D006442:Glycated Hemoglobin / Q000187:drug effects; D038321:Glycemic Index / Q000187:drug effects*; D006801:Humans; D007328:Insulin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D013995:Time
D001786:Blood Glucose; D005229:Fatty Acids, Monounsaturated; D006442:Glycated Hemoglobin; D007328:Insulin