Effect of lifestyle intervention on the risk of incident diabetes in individuals with impaired fasting glucose and low or high genetic risk for the development of type 2 diabetes in men: a T2D-GENE trial

PURPOSE: Genetic and lifestyle/environmental factors as well as their interplay contribute to the pathogenesis of type 2 diabetes (T2D). Several trials have shown that lifestyle intervention is effective in the prevention of T2D, but there are no trials that have taken into account the genetic risk of the participants. The aim of our T2D-GENE trial (ClinicalTrials.gov ID: NCT02709057) is to investigate the effects of lifestyle intervention on the prevention of T2D in participants with a high genetic risk of T2D compared with participants with a low genetic risk of T2D. METHODS: Both intervention and control groups include 300 participants with low and 300 participants with high genetic risk for T2D. Genetic risk was evaluated by genetic risk score, and these two groups were matched additionally for fasting plasma glucose concentration, age, and body mass index. Corresponding control groups (300 participants each) do not have lifestyle intervention. The inclusion criteria are impaired fasting glucose at entry with or without impaired glucose tolerance, age 50–75 years, and body mass index ≥25 kg/m(2). The primary outcome is incident T2D and the intervention lasts for 3 years. CONCLUSION: If the effects of the lifestyle intervention are independent from the genetic risk of the participants, our study will be of great importance for the entire T2D research community, health care providers, and individuals at high risk for T2D. In this case, lifestyle intervention is beneficial for all individuals at risk for developing T2D, independently of genetic risk. CLINICALTRIALS.GOV ID: NCT02709057 March 15, 2016