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OpenTrials
Completed

NCT Number: NCT05609266

Validation of Existing Diabetes Risk Models in a Swedish Population

The goal of this observational study is to validate existing non-invasive diabetes clinical prediction models in a Swedish population. The main question it aims to answer is: how well 11 existing models will perform in predicting incident type 2 diabetes in participants from the Västerbotten Intervention programme (VIP). Participants in VIP are residents of Västerbotten that are invited for a comprehensive health screening at 30- (until 1995), 40-, 50-, and 60-years of age.

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Key information

Conditions

Age range

28 year–62 year

Sex eligibility

All sexes

Study type

Observational

About this study

Several type 2 diabetes risk prediction models have been developed but how it will perform in a Swedish population is not known. No diabetes risk prediction model is routinely used in Sweden. The aim of this study is therefore, to validate 11 non-invasive models and to evaluate the performance to predict incident type 2 diabetes in a Swedish population. A population-based cohort from the Västerbotten Intervention programme (VIP) from 1990 to 2020 will be the validation sample. Incident type 2 diabetes within 10-years of follow-up, will be determined by oral glucose tolerance test or through self-reports. A self-administered questionnaire is completed, and anthropometric, clinical, and biochemical measures are obtained at each of the health screening visits. In the statistical analysis the overall performance of the models will be compared using the Brier score. In addition. discrimination and calibration of all the models will be evaluated. Recalibration of models will be done.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one visit within the Västerbotten Intervention program

Exclusion criteria

  • Prevalent diabetes at first visit defined by a fasting capillary plasma glucose >7mmol/L, a 2-hour capillary plasma glucose of ≥12.2 mmol/L or self-reported history of diabetes

Treatment and study plan

Primary outcomes

  1. Incident type 2 diabetes

    Time frame: 10-years

    Determined by a fasting capillary plasma glucose of ≥7 mmol/L or a 2-hour capillary plasma glucose of ≥12.2 mmol/L, or self-reported

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • University of Cambridge

Registry information

Official study title

Validation of Non-invasive Risk Models for Prediction of Incident Type 2 Diabetes in a Swedish Population

Important dates

Study start
1990
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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