Efficacy of Conventional and Intensified Lifestyle Interventions in Individuals with Prediabetes According to Risk Level
Lifestyle changes can prevent the development of type 2 diabetes in individuals with prediabetes, but according to current findings, these measures fail for a significant portion of study participants. In the Diabetes Prevention Program (DPP) study, one in five patients in the lifestyle intervention group developed type 2 diabetes within 4 years. However, there are individuals with prediabetes who do not develop diabetes without lifestyle intervention even after 11 years of follow-up. This indicates the need to create more precisely stratified intervention strategies based on the identification of high-risk (HR) and low-risk (LR) individuals with prediabetes. This is precisely the focus of a recently published study by German authors.
Methods and Study Progress
Prediabetes Lifestyle Intervention Study (PLIS) was a randomized controlled multicenter study conducted at 8 sites in university hospitals in Germany. Its primary objective was to assess the benefit of conventional intervention in low-risk prediabetes individuals and intensified intervention in high-risk prediabetes individuals.
A total of 1105 individuals with prediabetes diagnosed based on oGTT criteria by the American Diabetes Association (ADA) were stratified into HR or LR phenotypes. Stratification was based on insulin secretion thresholds, insulin sensitivity, and liver fat content. Participants in the LR group were then randomized in a 1:1 ratio. The control subgroup had no lifestyle intervention, while the intervention subgroup underwent conventional intervention. HR participants were randomized into a subgroup with conventional intervention or intensive intervention. The primary parameter monitored was the 2-hour blood glucose during oGTT after 12 months of intervention. Participants were then followed for 2 years.
Intervention Approach
In both conventional and intensified interventions, the goal was to reduce body weight by 5% in individuals with a BMI > 25 kg/m2, by reducing fat intake to < 30% of total energy intake and saturated fats to < 10% of total energy intake and increasing fiber intake to > 15 g/1000 kcal of total energy intake.
The conventional intervention consisted of 8 sessions over 1 year, with participants advised to engage in physical activity for 3 hours per week. In the intensified intervention, participants underwent 16 sessions over the year and were advised to engage in 6 hours of physical activity per week. During 30–60-minute sessions, they received nutrition education based on their own records of foods consumed over the previous 4 days. Physical activity consultations were based on accelerometer records. During each session, 5 goals were set: 3 dietary, 1 related to physical activity, and 1 concerning body weight.
Results
908 (82%) participants completed the 1-year evaluation. In the HR group, intensified intervention led to a reduction in 2-hour glucose during oGTT by 0.29 mmol/l (95% confidence interval [CI] −0.54 to −0.04; p = 0.025) compared to conventional intervention. In the LR group, there was no significant difference in this parameter between conventional intervention and no intervention (increase by 0.19 mmol/l; 95% CI −0.22 to 0.60; p = 0.4).
Over the entire 3-year follow-up, intensified intervention in HR individuals was associated with a higher conversion to normal glucose tolerance than conventional intervention (hazard ratio [HR] 1.57; 95% CI 1.17−2.10; p = 0.003). In the LR group, conventional intervention led to more frequent conversion to normal glucose tolerance than no intervention (HR 2.02; 95% CI 1.18−3.43; p = 0.01).
In HR individuals, intensified intervention compared to conventional intervention led to a 1.34 percentage point reduction in liver fat content (95% CI −2.17 to −0.5; p = 0.002) and a 1.82 percentage point reduction in cardiometabolic risk (95% CI −3.13 to −0.5; p = 0.007).
Conclusion
In high-risk prediabetes individuals, lifestyle intervention intensification can improve glycemic and cardiometabolic outcomes. Individualized intervention based on risk phenotype may help better target diabetes prevention.
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Source: Fritsche A., Wagner R., Heni M. et al. Different effects of lifestyle intervention in high- and low-risk prediabetes: results of the randomized controlled prediabetes lifestyle intervention study (PLIS). Diabetes 2021 Dec; 70 (12): 2785−2795, doi: 10.2337/db21-0526.
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