Breakfast replacement by a low-glycemic index liquid formula in patients with diabetes mellitus type 2.

Rationale:

Postprandial glucose excursions in diabetes mellitus are an important determinant of glycemic control. Postprandial glucose concentrations are determined by the amount and rate of carbohydrate absorption from the intestine, the prevailing insulin concentration and the potency of insulin to lower plasma glucose (insulin sensitivity). Consequently, food with lower postprandial glucose excursions (low-glycemic index food) may have a favourable effect in patients with diabetes mellitus.



Objective:

To determine the effect of breakfast replacement by a low-glycemic index (GI) liquid meal on postprandial glucose and insulin excursions, HbA1c, body weight and lipid profile in patients with diabetes mellitus type 2.



Study design:

Cross-over open-label intervention study.



Study population:

Patients with diabetes mellitus type 2, age 30-75y, body mass index 25-40 kg/m2.



Intervention:

Isoenergetic breakfast replacement by a low-GI liquid meal.



Main study parameters/endpoints:

24-hour glucose profile, body weight, HbA1c, insulin sensitivity, lipid profile.

N/A

Every 6 weeks: Fasting glucose, insulin, HbA1c and lipid concentrations, oxidative stress, body weight, continuous glucose monitoring;

Every 12 weeks: Postprandial glucose and insulin concentrations and oral glucose tolerance test.

Isoenergetic replacement of regular whole-food breakfast by Glucerna SR drinkvoeding (Abbott Laboratories B.V., Zwolle, Netherlands) will be compared to regular whole-food breakfast. Both will be given during 12 weeks.