Four-hour evaluation of a medical food in subjects with type 2 diabetes receiving oral hypoglycemic medication

Background: Postprandial hyperglycemia is an independent risk factor for diabetes-associated complications in individuals with type 2 diabetes. Dietary modification plays an important role in glycemic control. This study was to examine the efficacy of a diabetes specific formula (DSF) during a 4-hour postprandial meal tolerance test (MTT) in Russian subjects with type 2 diabetes receiving oral hypoglycemic medication. Methods: In a randomized, cross-over design, 168 eligible subjects from 11 study centers consumed, in a random order, the DSF (230 mL) or a common light hospital breakfast (i.e. standard meal) on two different occasions. The amounts of macronutrients were similar between the two meals providing ~200 kcal, 11 g protein, 26 g carbohydrate and 8 g fat. Capillary glucose levels were measured at baseline (before meal consumption), and post-meal consumption at 30, 60, 90, 120, 180 and 240 min. Results: The DSF was well tolerated in all subjects. There were 111 subjects completed the study per protocol (mean ± SEM: age: 58.6 ± 0.8 yr, BMI: 31.8 ± 0.42 kg/m2, waist circumference: 101 ± 1.3 cm, HbA1c: 8.0% ± 0.1%). Glucose levels reached peak values at 60 min (median) and the lowest levels at the end of the 240-min MTT test. The mean positive area under the curve (PAUC), the primary outcome, was significantly smaller after DSF consumption (mean ± SEM: 183.02 ± 18.74, median: 132.55) than the PAUC after consumption of the standard meal (mean ± SEM: 239.95 ± 23.11, median: 166.89; p = 0.027). The actual and adjusted peak glucose concentrations were similar between the two treatments. Conclusions: In patients with type 2 diabetes receiving oral hypoglycemic agents, compared to a hospital meal, the DSF improves postprandial glucose control. Combining results from earlier studies, long-term use of DSF may be beneficial to improve glucose management and decrease diabetes-associated complications.