Development and validation of a risk-score model for subjects with impaired glucose tolerance for the assessment of the risk of type 2 diabetes mellitus—The STOP-NIDDM risk-score

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Abstract

Aims

To develop a risk-score model, based on available clinical data to assess absolute risk of type 2 diabetes among people with impaired glucose tolerance (IGT).

Methods

Data from the study to prevent non-insulin dependent diabetes mellitus (STOP-NIDDM) investigating acarbose treatment in individuals with IGT were used to develop multivariable Cox proportional hazards model for the time to onset of diabetes. The final model equation was externally validated using data from the Finnish Cardiovascular Risk Factor (FINRISK) population.

Results

The risk-score model included the variables acarbose treatment, gender, serum triglyceride level, waist circumference, fasting plasma glucose, height, history of cardiovascular disease (CVD) and hypertension. The final model yielded an area under the receiver-operating-characteristic curve (AUCROC) of 0.64 when applied to people with IGT in the STOP-NIDDM, and 0.84 and 0.90 when applied to FINRISK population with IGT alone and IGT and normal glucose tolerance combined, respectively; AUCROC is a measure of the discriminatory power of the model (1, perfect discrimination).

Conclusions

The STOP-NIDDM risk-score is a simple and validated tool that can identify high-risk individuals with IGT who would benefit most from type 2 diabetes or CVD prevention strategies, such as lifestyle management or early acarbose treatment.

Introduction

It is now widely appreciated that we are experiencing a global epidemic of type 2 diabetes. In 2003, the International Diabetes Federation (IDF) estimated that 194 million people worldwide had diabetes; this figure is expected to increase to more than 300 million by 2025 [1]. The prevalence of prediabetes is estimated to be even higher, and increasing at a similar rate [1]. Beating this epidemic will require widespread action to increase the early identification and treatment of dysglycaemia, especially in people likely to progress to type 2 diabetes [2]. Straightforward, inexpensive methods of identifying individuals at high risk of developing type 2 diabetes – individuals who would benefit most from treatment – are therefore extremely valuable [3] (Fig. 1).

In many other therapeutic areas of chronic diseases, the use of risk-prediction tools is common. There are, for example, numerous tools available to assess an individual's risk of developing cardiovascular disease (CVD), including the European SCORE [4] and PROCAM score [5], the New Zealand score [6], and the US Framingham 1991 and 1998 scores [7], [8]. Recently, a risk-score has also been developed to predict dementia on the basis of simple risk factors [9].

Such tools estimate an individual's risk of having a defined ‘event of interest’. In prediabetes, the event of interest is the transition from impaired glucose tolerance (IGT) to type 2 diabetes [10], [11]. There is also strong evidence to indicate that this progression can be halted or reduced by lifestyle or pharmacological interventions [12], [13]. Stern et al. have noted that the standard method of identifying individuals at high risk for type 2 diabetes is a somewhat costly and inconvenient 2-h oral glucose tolerance test (OGTT) to determine whether they have IGT [14]. In most cases, minimal or no attention is paid to the effects of other known risk factors for type 2 diabetes, such as advanced age and obesity.

Consequently, risk-scores have been developed for the prediction of type 2 diabetes that do take account of such factors, including the FINDRISC score [15], the American Diabetes Association diabetes risk test [16], the Thai risk-score [17] and several other scores derived from various European [18], [19], [20], [21], [22], [23], [24], American [25], [26], [27], [28], Indian [29] and Arab [30] population studies. These tools are based on traditional risk factors for type 2 diabetes. The evidence increasingly indicates that the effect of metabolic factors such as hyperlipidaemia and hypertension should also be considered [27], [31]. Such tools would allow wider screening, reduce the number of individuals with undiagnosed prediabetes or type 2 diabetes who remain undetected, and help to improve healthcare provision. It is well-known that people with IGT have a high probability to progress to diabetes; approximately half of them are diabetic within 10 years [32], [33]. The rate of progression among people with IGT depends on their risk factor profile, and thus type 2 diabetes risk-scores may provide a way to predict the risk also in people with IGT. This way it would be possible to identify those people with IGT who are at the highest risk and who may most benefit from preventive interventions, as demonstrated with the FINDRISC in the Finish Diabetes Prevention Study recently [34].

The objective of the present study was to develop and validate a simple model to predict the risk of development of type 2 diabetes in individuals with IGT.

Section snippets

Subjects

Data from the STOP-NIDDM study population were used to develop the model. STOP-NIDDM was a double-blind, placebo-controlled, randomised trial conducted in nine countries (Canada, Germany, Austria, Norway, Denmark, Sweden, Finland, Israel and Spain). Details of the study and its findings have been described elsewhere [35], [36], [37] and are briefly summarised below.

Participants were recruited from a high-risk population, aged between 40 and 70 years, with a body mass index (BMI) between 25 and

Results

A risk-score model was developed using a Cox PH approach based on data from 1160 individuals who completed STOP-NIDDM. The eight variables included in the final model were: the presence or absence of acarbose treatment, gender, serum triglyceride level, waist circumference, FPG level, height, baseline history of CVD, and diagnosed hypertension. Each of these variables was significantly associated with an individual's risk of type 2 diabetes (P  0.05). Descriptive statistics, regression

Discussion

The present manuscript reports the development of a simple and validated tool to estimate an individual's risk of developing diabetes in the next 2.5 years. The tool can be used to identify individuals with IGT at the highest risk of developing type 2 diabetes, who are likely benefit most from prevention strategies.

Importantly, the tool is based on commonly available demographic and clinical data. The eight variables included – acarbose treatment, gender, serum triglyceride level, waist

Conflict of interest

JT has received reimbursements of travel expenses, research grants and lecture fees from Bayer HealthCare. Martin Hellmich and Walter Lehmacher have been working on this project paid by Bayer; Torsten Westermeier, Thomas Evers and Andreas Brückner are empoyed by Bayer. The STOP-NIDDM trial where Jean-Louis Chiasson is the Principal Invsestigator was sponsored by Bayer. This present work was carried out by an educational grant from Bayer to the University of Helsinki.

Acknowledgements

This work was partially funded by an unrestricted grant from Bayer HealthCare. Editorial assistance was provided by Gardiner-Caldwell London.

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