Diabetes Research on Patient Stratification

Study Overview
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Brief Summary
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The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).

Detailed Description
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There are two multicentre prospective cohort studies within the glycaemic deterioration work package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic deterioration by amassing data and biomaterials that will be used to discover novel biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes (Study 1) and in those who have recently been diagnosed with the disease (Study 2).

Official Title
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DIabetes REsearCh on Patient straTification

Conditions
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Type2 Diabetes

Participation Criteria
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Eligibility Criteria
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Study 1 Inclusion criteria No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs Fasting capillary blood glucose <10 mmol/l at baseline White European (self-report of parental ethnicity) Age ≥35 and <75 years Exclusion criteria Diagnosed diabetes of any type, HbA1c ≥6.5% (48 mmol/mol) or fasting plasma glucose ≥7.0 mmol/l or 2 h plasma glucose >11.0 mmol/l previously For women, pregnancy, lactation or plans to conceive within the study period Use of a pacemaker Any other significant medical reason for exclusion as determined by the investigator Study 2 Inclusion Criteria: Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination Management by lifestyle with or without metformin therapy All HbA1c <7.6% (<60 mmol/mol) within previous 3 months White European Age ≥35 and <75 Estimated GFR >50 ml/min' Exclusion Criteria: Type 1 diabetes A previous HbA1c >9.0% (>75 mmol/mol) Prior treatment with insulin or an oral hypoglycaemic agent other than metformin BMI <20 or >50 kg/m2 Pregnancy, lactation or plans to conceive within the study period Any other significant medical reason for exclusion as determined by the investigator

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study 1 - Prediabetes<br>The primary objective of Study 1 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in non-diabetic high-risk participants. Participants in Study 1 were recruited from existing prospective cohort studies in or around each of the following European cities: Malmö, Sweden (Malmö Diet and Cancer Study); Amsterdam, The Netherlands (Hoorn Study); Copenhagen, Denmark (Inter99); and Kuopio, Finland (METSIM). A clinically practicable screening tool (DIRECT-DETECT) was used to identify at-risk participants from existing cohort studies, who were then recruited into this new prospective cohort study (Study 1). | |
| Study 2- Diabetic<br>The primary objective of Study 2 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in people who have recently been diagnosed with type 2 diabetes. Participants in Study 2 of DIRECT are recruited from or nearby each of the following European cities: Malmö, Sweden; Amsterdam, the Netherlands; Copenhagen, Denmark; Exeter, UK; Newcastle, UK; Dundee, UK. Potential participants are recruited through targeted searches of existing databases and research registers combined with person-to-person contact at educational clinics and through routine retinal screening programmes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic deterioration | Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin | Up to 10 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gene-environment interaction, Glycaemic control, Lifestyle, Genome, Microbiome, Prediabetes, Proteome, Type 2 diabetes