Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients

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.

A systematic review and meta‐analysis of the effectiveness of meal replacements for weight loss

“…Fourteen studies were conducted in people who were overweight but with no specific clinical condition, five in people with type 2 diabetes, two in participants with metabolic syndrome or impaired glucose regulation, one in men with type 2 diabetes and erectile dysfunction, and one in adults with developmental disabilities and obesity …”

“…In 15 studies (65%), the MR used consisted of specially formulated shakes, soups, or bars . In four studies (17%), the MR consisted of prepackaged portion‐controlled meals which participants reconstituted or cooked at home, and in four studies (17%), the MR was a combination of prepackaged portion‐controlled meals and specially formulated shakes, soups, or bars …”

“…Twelve studies also included a second MR phase for continued weight loss or weight maintenance where continued use of MR was recommended, generally at a reduced level. The median duration of this phase was 42 weeks [IQR 30 to 52 weeks] …”

“…During the weight loss phase, 13 studies advised participants to replace two eating occasions each day with a MR . One study advised participants to replace one eating occasion, and one, two, and four studies advised participants to replace three, four, or five eating occasions (meals or snacks) with one MR, respectively.…”

“…In 15 studies, in addition to the MR diet, participants also received support for weight loss during the active intervention. This support consisted of 12 sessions [IQR 7 to 19] over 24 weeks, ranging from 12 to 52 weeks [IQR 12 to 52 weeks] (MR diet + support) . In two studies (four intervention arms), an enhanced level of support was offered to the MR group (73 sessions [IQR 57.5 to 88.5 sessions] over 78 weeks [IQR 65 to 91 weeks]) compared with the support provided to the control group which consisted of two sessions [IQR 2 to 2] over 78 weeks [IQR 65 to 91 weeks]) (MR diet + enhanced support) …”