Multidisciplinary lifestyle management approach in patients with type 2 diabetes mellitus in real clinical practice. Results of application “Life is easy” programme in Russia

Abstract

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a disease with high medical and social impact due to its wide and ever-increasing prevalence, high hospitalization and mortality rates. Despite the whole range of therapeutic options, lifestyle intervention remains as important as ever since it underlies guidelines of T2DM management.
 AIMS: To evaluate the effect of intensive lifestyle management approach on body weight reduction and on long-term maintenance of the achieved results in patients with T2DM.
 MATERIALS AND METHODS: We performed multicenter, interventional, prospective, non-randomized 12 month study. One hundred thirty overweight (obese) patients with T2DM included in the study were divided into two groups: group of lifestyle intervention (n=100) and control group (n=30). Patients in the group of lifestyle intervention participated in the intensive lifestyle modification and body weight reduction programme, which consisted of components: change in diet plan, physical exercise programme, cognitive behavioral techniques, educational and medical support. Clinical assessment and completing of patient questionnaires were performed at baseline, after 3 and 12 months. Patients in the control group did not attend programme, their clinical data were recorded during clinical visits every 3 months.
 RESULTS: Ninety patients (90%) in the group of lifestyle intervention and twenty nine patients (96.7%) in the control group completed the study and fulfilled protocol. After 12 months, patients in the group of lifestyle intervention lost 5.8% of their baseline weight and patients in the control group showed 1.2% decrease of their baseline weight. Body weight loss 5% was observed in 49.2% of patients in the group of lifestyle intervention and in 12.9% of patients in the control group (OR=6.54 [2.01; 21.33]; р=0.002). By the end of observation, delta reduction of glycated hemoglobin (HbA1c) in the intervention group was higher than in the control group (0.79% and 0.11%, respectively), the odds ratio for lowering HbA1c 0.5% from baseline between two groups was 14.10 [3.24; 61.30] (p0.001) in favor of the group of lifestyle intervention. 58.3% patients in the group of lifestyle intervention with baseline level of HbA1c 7% (n=48) achieved a HbA1c target of 7%; in the control group two patients (13.3%) out of fifteen with baseline level of HbA1c 7% achieved the target after 3 months and returned to baseline by the end of observation.
 CONCLUSIONS: Our results suggest that the programme of intensive lifestyle modification in patients with T2DM is highly efficient and safe.

Lifestyle modification program, LIFE is LIGHT, in patients with type 2 diabetes mellitus and obesity: Results from a 48‐week, multicenter, non‐randomized, parallel‐group, open‐label study

“…The reduction in the levels of HbA1c is depicted in Figure 5 . 27 No statistically significant difference in the FBG level was observed between the groups during the study.…”

“…The odds of a decrease in body weight of ≥5% at Week 48 of the follow‐up were statistically significantly higher among the patients in the ILM group compared with those in the ST group (OR: 6.54; 95% CI: 2.01, 21.33; p = 0.002). The reduction in body weight in patients of the ILM group, including those who achieved the primary endpoint (weight loss ≥5%), in the first 3 months of program has been presented in Figure 3 27 …”

“…The reduction in body weight in patients of the ILM group, including those who achieved the primary endpoint (weight loss ≥5%), in the first 3 months of program has been presented in Figure 3 . 27 …”

“…Overall, a steady and significant decrease in body weight was observed in the ILM versus control group from baseline until end of the study (Figure 4 ). 27 The percentage changes in body weight from baseline to Week 12, 24, 36, and 48 and the corresponding between group comparisons are presented in Table 2 .…”

“…Although the Look AHEAD trial did not show that an intensive lifestyle intervention reduced CV events in adults with T2DM and obesity, it did show the feasibility of achieving and maintaining long‐term weight loss in patients with T2DM. 27 However, the post hoc analysis of the Look AHEAD showed that 85% of patients with moderately or well‐controlled HbA1c and good overall health had reduced CV events, whereas 15% of participants with well‐controlled HbA1c and poor health experienced negative effects; this may have resulted in an overall neutral outcome of the study. 28 …”