Diabetes Research on Patient Stratification (DIRECT)

Lund University

Status: Completed

Conditions: Type2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT03814915

IMIDIRECT_2012

Details and patient eligibility

About

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).

Full 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).

Enrollment: 3,049 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

3,049 participants in 2 patient groups

Study 1 - Prediabetes

Description:

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

Description:

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.