OBJECTIVE: To investigate the effect of a new enteral nutrition suspension (diabetes) (TPF-DM) (Dixson 0.75 kcal/ml) (1 kcal = 4.184 kJ) on blood glucose, serum insulin and lipids as compared with a standard formula (Nutrition MF 0.75 kcal/ml) in patients with type 2 diabetes. METHODS: A randomized, controlled, paralleled and single center trial was carried out. A total of 76 patients with type 2 diabetes without using insulin and obvious complications were randomized into a study group and a control group. 36 patients in the study group and 35 in the control group completed the trial. The observation lasted 6 days. All calories came from enteral nutrition. At baseline all the patients had standard mixed meal (bread 50 g, egg 50 g, milk 250 ml, total calorie 400 kcal) test and at the end of the trial a enteral nutrient meal (enteral nutrient 400 ml, total calorie 300 kcal) test. Blood samples were taken before the meal and 30, 60, 120 and 180 minutes after the meal to test plasma glucose, serum insulin, serum lipids and some safety parameters. The area under curve (AUC) for plasma glucose, serum insulin, serum lipids was calculated. RESULTS: Compared with the mixed meal test, the AUC of plasma glucose and serum insulin during both Dixson 0.75 kcal/ml test and standard formula (Nutrition MF 0.75 kcal/ml) test were significantly lower (P < 0.01). The change at baseline in the study group was more than that in the control group [the change of AUC for plasma glucose (-6.42 +/- 8.62) h x mmol x L(-1) vs (-1.87 +/- 5.30) h x mmol x L(-1), P < 0.01; that of AUC for serum insulin (-36.94 +/- 49.77) h x mIU x L(-1) vs (-18.20 +/- 32.62) h x mIU x L(-1), P < 0.05]. Both the enteral nutrition formula can reduce insulin resistance (calculated by HOMA-IR), but there was no difference between them. There was no significant effect on total cholesterol, high density lipoprotein and low density lipoprotein. AUC of serum triglycerides was lower during the tests with both enteral nutrients than that during mixed meal test, but there was no significant difference between the two groups. There was no safety concern about the enteral nutrition. CONCLUSION:Enteral nutrition suspension (diabetes) (TPF-DM) (Dixson 0.75 kcal/ml) is an effective and safe enteral nutrient to be used in patients with type 2 diabetes.
RCT Entities:
OBJECTIVE: To investigate the effect of a new enteral nutrition suspension (diabetes) (TPF-DM) (Dixson 0.75 kcal/ml) (1 kcal = 4.184 kJ) on blood glucose, serum insulin and lipids as compared with a standard formula (Nutrition MF 0.75 kcal/ml) in patients with type 2 diabetes. METHODS: A randomized, controlled, paralleled and single center trial was carried out. A total of 76 patients with type 2 diabetes without using insulin and obvious complications were randomized into a study group and a control group. 36 patients in the study group and 35 in the control group completed the trial. The observation lasted 6 days. All calories came from enteral nutrition. At baseline all the patients had standard mixed meal (bread 50 g, egg 50 g, milk 250 ml, total calorie 400 kcal) test and at the end of the trial a enteral nutrient meal (enteral nutrient 400 ml, total calorie 300 kcal) test. Blood samples were taken before the meal and 30, 60, 120 and 180 minutes after the meal to test plasma glucose, serum insulin, serum lipids and some safety parameters. The area under curve (AUC) for plasma glucose, serum insulin, serum lipids was calculated. RESULTS: Compared with the mixed meal test, the AUC of plasma glucose and serum insulin during both Dixson 0.75 kcal/ml test and standard formula (Nutrition MF 0.75 kcal/ml) test were significantly lower (P < 0.01). The change at baseline in the study group was more than that in the control group [the change of AUC for plasma glucose (-6.42 +/- 8.62) h x mmol x L(-1) vs (-1.87 +/- 5.30) h x mmol x L(-1), P < 0.01; that of AUC for serum insulin (-36.94 +/- 49.77) h x mIU x L(-1) vs (-18.20 +/- 32.62) h x mIU x L(-1), P < 0.05]. Both the enteral nutrition formula can reduce insulin resistance (calculated by HOMA-IR), but there was no difference between them. There was no significant effect on total cholesterol, high density lipoprotein and low density lipoprotein. AUC of serum triglycerides was lower during the tests with both enteral nutrients than that during mixed meal test, but there was no significant difference between the two groups. There was no safety concern about the enteral nutrition. CONCLUSION: Enteral nutrition suspension (diabetes) (TPF-DM) (Dixson 0.75 kcal/ml) is an effective and safe enteral nutrient to be used in patients with type 2 diabetes.