Diabetes Research on Patient Stratification
- Conditions
- Type2 Diabetes
- Registration Number
- NCT03814915
- Lead Sponsor
- Lund University
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3049
- 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'
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycemic deterioration Up to 10 years follow-up Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin
- Secondary Outcome Measures
Name Time Method