Clinical trial NCT05609266: Validation of Existing Diabetes Risk Models in a Swedish Population
Official title: Validation of Non-invasive Risk Models for Prediction of Incident Type 2 Diabetes in a Swedish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2diabetes
Keywords: Non-invasive prediction model
Incident diabetes
Validation
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2022-11-08
Enrollment: 115642
Sex: ALL
Minimum age (years): 28
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhabitants from the Västerbotten region in Sweden that have been invited to participate in the Västerbotten Intervention Program for a comprehensive health screening at 30 (stopped in 1995) 40, 50 and 60 years of age.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incident type 2 diabetes
timeFrame: 10-years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Olov Rolandsson, MD
role: PRINCIPAL_INVESTIGATOR
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