Meal replacement reduces insulin requirement, HbA1c and weight long-term in type 2 diabetes patients with >100 U insulin per day

BackgroundDespite high insulin doses, good glycaemic control is often lacking in type 2 diabetes patients and new therapeutic options are needed. MethodsIn a proof of principle study, an energy-restricted, protein-rich meal replacement (PRMR) was examined as a means of reducing insulin requirement, HbA1C and body weight. Obese type 2 diabetes patients (n=22) with >100U insulin per day replaced, in week 1, the three main meals with 50g of PRMR (Almased-Vitalkost) each (=4903kJday(-1)). In weeks 2-4, breakfast and dinner were replaced, and, in weeks 5-12, only dinner was replaced. Clinical parameters were determined at baseline, and after 4, 8 and 12weeks, as well as after 1.5years of follow-up. The Wilcoxon signed-rank test was used for the intention-to-treat analysis and the Mann-Whitney U-test for subgroup analyses. ResultsThe 12-week-programme was completed by 15 participants (68%). After 1week, the mean insulin dose was reduced from 147(75)U to 91(55)Uday(-1) (P=0.0001), and to 65(32)U (P<0.0001) after 12weeks of study. Over a period of 12weeks, HbA1c decreased from 8.8%(1.4%) to 8.1%(1.6%) (P=0.048) and weight decreased from 118.0(19.7)kg to 107.4(19.2)kg (P<0.0001). Moreover, body mass index, waist and hip circumference, fasting blood glucose, triglycerides and high-density lipoprotein cholesterol improved significantly. After 1.5years, insulin requirement and weight remained significantly lower than baseline. Participants who continued PRMR further reduced their HbA1c, weight and insulin dose. Two patients were able to stop insulin therapy altogether. ConclusionsEnergy-restricted PRMR was effective in reducing insulin requirement of type 2 diabetes patients with intensified insulin therapy accompanied by a reduction of HbA1c, weight and other cardiometabolic risk factors. With the continuous use of PRMR, glycaemic control might be improved in the long term.