Kerstin Kempf, Martin Röhling, Katja Niedermeier, Babette Gärtner, Stephan Martin
Journal: Nutrients 2018;10(8):1022
PMID: 30081574
This randomised study investigated the benefits of a low carbohydrate diet with meal replacements in patients with type 2 diabetes (T2DM). T2DM patients with poorly controlled glucose levels and a body mass index (BMI) ≥ 27 kg/m2 were included in the study and randomised to either a strict (S) or moderate (M) intervention group. A control (C) group was also enrolled. Meal replacement and self-monitoring blood glucose (SMBG) were individually recommended and study visits took place at 1, 4 and 12 weeks. Clinical and biochemical data were measured at baseline, after 12 weeks of intervention, and after 52 weeks of follow-up and included HbA1c, fasting blood glucose, total cholesterol, high-density-lipoprotein (HDL), and low-density-lipoprotein (LDL) cholesterol; medication use was also monitored. Intervention group patients were advised on a low carbohydrate diet. During the first week the S-group replaced all meals and the M-group two meals with the replacement drink. Thereafter intervention was the same for both groups: during weeks 2-4 two meal replacements were used, from week 5 one meal replacement, whilst adhering to a low carbohydrate diet. Drop out rate was 17% after 12 weeks and 28% after 52 weeks. The authors found that their individualized meal replacement based low-carbohydrate diet intervention can produce clinically-relevant improvements in HbA1c, body weight, fasting blood glucose, quality of life, eating behaviour, and other cardiometabolic risk factors, comparable to bariatric surgery but without any adverse effects.
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. Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day ( = 160) or a stringent group (S-group) with three meal replacements/day ( = 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 ( = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. 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 < 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 ( > 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] ( < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. 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.
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