Introduction: Increasing evidence shows that type 2 diabetes mellitus (T2DM) could be reversible and that this is related to weight loss. Significant weight loss achieved through bariatric surgery or medically can result in diabetes remission. Diabetes remission is more likely to occur in those who are younger, have shorter duration of disease, and are on fewer diabetes medications. The impact of using a low energy formula-based diet in combination with physical activity on T2DM in younger patients with early T2DM has not been tested. DIADEM-1 is a randomized controlled trial comparing such an intensive lifestyle intervention (low energy diet with physical activity) with best medical care (BMC; lifestyle advice and medical optimization for body weight and diabetes). We report early 3-month findings from DIADEM-1.
Methods: Subjects (n=112) with early T2DM (<=3 years) and obesity (BMI>=27 kg/m2) aged 1850 years were recruited into the Diabetes Intervention Accentuating Diet and Enhancing Metabolism 1 (DIADEM-1) randomised controlled clinical trial. Subjects were randomized into the ILI and BMC groups. All participants received baseline and 3-month assessments including anthropometric measurements, and collection of fasted blood samples. Key outcomes are reported from 3 months into the study.
Results: There were no baseline differences between the ILI and BMC groups. About 1/3 of participants were women. At 3 months, there was significant weight loss in the ILI group compared to the BMC group (ILI 12.89 Kg; 95%CI: 11.0414.74 Vs BMC 3.17 Kg 95%CI: 2.274.07; P<0.0001). The ILI group had significantly lower fat mass (bioimpedance) at 3 months (ILI 27.55 Kg 95%CI:24.3030.80 Vs BMC 35.62 Kg 95%CI:31.7339.52; P=0.0024), but no difference in muscle mass, suggesting that muscle mass was preserved. HbA1c was significantly lower in the ILI group despite no/lower medications for T2DM (ILI 5.8% 95%CI:5.56.0% Vs BMC 6.4% 95%CI:6.16.7%; P=0.0016).
Conclusion: It is possible to achieve significant weight loss and diabetes improvement/remission in younger patents with early T2DM using an ILI that combines a low energy diet though meal replacements with physical activity. It remains to be seen if this effect is sustained.