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.

Ursula Schwab,Maria Lankinen,Markku Laakso

doi:10.29219/fnr.v65.7721

Abstract

PurposeGenetic 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.MethodsBoth 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/m2. The primary outcome is incident T2D and the intervention lasts for 3 years.ConclusionIf 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 IDNCT02709057 March 15, 2016

Highlights

The prevalence of diabetes mellitus will likely increase globally from 463 million individuals in 2019 to 700 million individuals in 2045 [1]
The aim of the type 2 diabetes mellitus (T2D)-GENE trial is to investigate the effects of lifestyle intervention on the prevention of incident T2D and the worsening of hyperglycemia in people with a high number of T2D risk alleles compared with people with a low number of T2D risk alleles
The hypotheses of the study are that lifestyle intervention is efficient independent of the number of T2D risk alleles, and that a group-based intervention is as effective as an individual-based intervention in the prevention of T2D

Summary

Introduction

The prevalence of diabetes mellitus will likely increase globally from 463 million individuals in 2019 to 700 million individuals in 2045 [1]. Several studies have indicated that lifestyle intervention is effective in the prevention of T2D. People with combined IFG and IGT have a combination of increased gluconeogenesis, lack of suppression of glycogenolysis by insulin, impaired glucose disposal with extrahepatic insulin resistance, and impaired insulin secretion [7]. The aim of the T2D-GENE trial is to investigate the effects of lifestyle intervention (diet, physical activity, and weight maintenance/weight loss) on the prevention of incident T2D and the worsening of hyperglycemia in people with a high number of T2D risk alleles compared with people with a low number of T2D risk alleles. The hypotheses of the study are that lifestyle intervention is efficient independent of the number of T2D risk alleles (high and low genetic risks of T2D), and that a group-based intervention is as effective as an individual-based intervention in the prevention of T2D

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