Skip to content

Diabetes Research on Patient Stratification

DIabetes REsearCh on Patient straTification

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03814915
Acronym
DIRECT
Enrollment
3049
Registered
2019-01-24
Start date
2012-10-15
Completion date
2019-07-31
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Keywords

Gene-environment interaction, Genome, Glycaemic control, Lifestyle, Microbiome, Prediabetes, Proteome, Type 2 diabetes

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).

Interventions

None listed

Sponsors

Lund University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 74 Years
Healthy volunteers
No

Inclusion 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'

Design outcomes

Primary

MeasureTime frameDescription
Glycemic deteriorationUp to 10 years follow-upChange in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026