Abstract
Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care.
Highlights
Current type 2 diabetes mellitus guidelines recommend lifestyle intervention as basic treatment.patients often fail to improve their eating behavior, physical activity, body weight, and glycemic control in the long run
A failing lifestyle intervention contributes to an initiation of a pharmaceutical co-intervention in the step, anti-diabetic medication does not prevent the progression of type 2 diabetes [3]
We hypothesize that the strict rules, the stringent and individual self-monitoring of blood glucose (SMBG) [17], and the complete replacement of all meals in the stringent group (S-group) during the first week contributed to a subtler change of behavior and higher motivation for the diet, which was shown to be necessary for long-term changes of behavior in high-risk individuals for type 2 diabetes in prior studies [19]
Summary
Current type 2 diabetes mellitus guidelines recommend lifestyle intervention as basic treatment.patients often fail to improve their eating behavior, physical activity, body weight, and glycemic control in the long run. Glycemic control improves within a few days, even before a decrease of body weight becomes apparent [7], but this treatment has several severe side-effects [8] and long-term effects are still unclear [9]. We had already investigated the single or combined effect of low-carbohydrate formula diets and/or telemedicine in patients with type 2 diabetes inducing HbA1c, anti-diabetic medication, and body weight improvements [12,16]. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within
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