Status:
COMPLETED
Diabetes Research on Patient Stratification
Lead Sponsor:
Lund University
Conditions:
Type2 Diabetes
Eligibility:
All Genders
35-74 years
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 pr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 15 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
3049 Patients enrolled
Trial Details
Trial ID
NCT03814915
Start Date
October 15 2012
End Date
July 31 2019
Last Update
January 18 2020
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