DIabetes REsearCh on Patient straTification
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type2 Diabetes
- Sponsor
- Lund University
- Enrollment
- 3049
- Primary Endpoint
- Glycemic deterioration
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Glycemic deterioration
Time Frame: Up to 10 years follow-up
Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin