Dataset Information

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.

ABSTRACT:

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/m². 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.

Clinicaltrialsgov id

NCT02709057 March 15, 2016.

SUBMITTER: Schwab U

PROVIDER: S-EPMC8494262 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundDiabetes is associated with higher fracture risk despite higher bone mineral density (BMD), with FRAX® underestimating risk. This study aimed to investigate FRAX score with and without BMD for women with normoglycaemia, impaired fasting glucose (IFG) and diabetes.MethodsAmong 566 women, aged 40-90?years, enrolled in the Geelong Osteoporosis Study, IFG was defined as fasting plasma glucose (FPG) ?5.5?mmol/L and diabetes as FPG???7.0?mmol/L, use of antihyperglycaemic medication and/or self-report. FRAX (Australia) 10-year probabilities of major osteoporotic (MOF) and hip fracture were calculated, with and without BMD, producing four FRAX scores per participant. Kruskal-Wallis test for non-parametric data was used to examine differences between the three glycaemia groups. Fractures over 10?years were ascertained using radiological reports. The number of fractures predicted by FRAX was compared with the number of fractures observed using Chi-square tests.ResultsFor MOF FRAX calculated without BMD, women with diabetes (n?=?67) tended to have a higher median score 7.1 (IQR 2.7-12.0) than normoglycaemia (n?=?252) (4.3 (IQR 1.9-9.9) and IFG (n?=?247) (5.1 (IQR 2.2-9.6)). For hip FRAX without BMD, diabetes tended to have a higher score (2.5 (IQR 06-4.3)) than normoglycaemia (1.2 (IQR 0.3-4.1)) and IFG (1.3 (IQR 0.3-4.1)). In the normoglycaemia and IFG groups, MOFs were underestimated; 15 predicted vs 28 observed, p?=?0.038; and 16 predicted vs 31 observed, p?=?0.021, respectively. Fractures were accurately estimated in all other groups.When including BMD, the association with diabetes was non-significant for both MOF FRAX (normoglycaemia 3.7 (IQR 1.9-8.0), IFG 4.3 (IQR 2.2-8.1) and diabetes 5.3 (IQR 2.7-9.4)) and hip FRAX scores (normoglycaemia 0.6 (IQR 0.2-2.5), IFG 0.8 (IQR 0.2-2.7) and diabetes 1.0 (IQR 0.3-3.0)). For normoglycaemia and IFG, MOFs were underestimated (normoglycaemia: 13 predicted vs 28 observed and IFG: 13 vs 31). For diabetes, both MOFs and hip fractures tended to be underestimated by FRAX with BMD (MOF: 4 predicted vs 11 observed, p?=?0.055, hip: 1 predicted vs 6 observed, p?=?0.052). Hip fractures were accurately estimated in the normoglycaemia and IFG groups.ConclusionsCompared with women who had normoglycaemia or IFG, women with diabetes tended to have a higher FRAX score for both MOF and hip fractures when BMD was not included. When BMD was included, there was no difference. Fractures in diabetes tended to be underestimated by FRAX with BMD. This suggests that FRAX calculations including BMD may not be accurate for estimating fractures in those with diabetes.