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CompletedNCT03814915DIRECTUpdated Jan 18, 2020

Diabetes Research on Patient Stratification

An observational study in Type2 Diabetes, sponsored by Lund University. Completed. Open to participants aged 35 Years to 74 Years. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Lund University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,049
Ages
35 Years to 74 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Type2 Diabetes

Keywords

  • Gene-environment interaction
  • Genome
  • Glycaemic control
  • Lifestyle
  • Microbiome
  • Prediabetes
  • Proteome
  • Type 2 diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 3,049 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

White European (self-report of parental ethnicity), Age ≥35 and \<75 years

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,049 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study 1 - Prediabetes

    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

    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.

06

What researchers measure

Primary outcomes

  1. Glycemic deterioration

    Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin

    Time frame: Up to 10 years follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Koivula RW, Heggie A, Barnett A, Cederberg H, Hansen TH, Koopman AD, Ridderstrale M, Rutters F, Vestergaard H, Gupta R, Herrgard S, Heymans MW, Perry MH, Rauh S, Siloaho M, Teare HJ, Thorand B, Bell J, Brunak S, Frost G, Jablonka B, Mari A, McDonald TJ, Dekker JM, Hansen T, Hattersley A, Laakso M, Pedersen O, Koivisto V, Ruetten H, Walker M, Pearson E, Franks PW; DIRECT Consortium. Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes: rationale and design of the epidemiological studies within the IMI DIRECT Consortium. Diabetologia. 2014 Jun;57(6):1132-42. doi: 10.1007/s00125-014-3216-x. Epub 2014 Apr 4. PubMed 24695864 ↗
  • Atabaki-Pasdar N, Ohlsson M, Vinuela A, Frau F, Pomares-Millan H, Haid M, Jones AG, Thomas EL, Koivula RW, Kurbasic A, Mutie PM, Fitipaldi H, Fernandez J, Dawed AY, Giordano GN, Forgie IM, McDonald TJ, Rutters F, Cederberg H, Chabanova E, Dale M, Masi F, Thomas CE, Allin KH, Hansen TH, Heggie A, Hong MG, Elders PJM, Kennedy G, Kokkola T, Pedersen HK, Mahajan A, McEvoy D, Pattou F, Raverdy V, Haussler RS, Sharma S, Thomsen HS, Vangipurapu J, Vestergaard H, 't Hart LM, Adamski J, Musholt PB, Brage S, Brunak S, Dermitzakis E, Frost G, Hansen T, Laakso M, Pedersen O, Ridderstrale M, Ruetten H, Hattersley AT, Walker M, Beulens JWJ, Mari A, Schwenk JM, Gupta R, McCarthy MI, Pearson ER, Bell JD, Pavo I, Franks PW. Predicting and elucidating the etiology of fatty liver disease: A machine learning modeling and validation study in the IMI DIRECT cohorts. PLoS Med. 2020 Jun 19;17(6):e1003149. doi: 10.1371/journal.pmed.1003149. eCollection 2020 Jun. PubMed 32559194 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03814915
Lead sponsor
Lund University
Responsible party
Sponsor
First posted
Jan 24, 2019
Start date
Oct 15, 2012
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Jan 18, 2020

Study contacts

Ewan Pearson, FRCP
principal investigator · University of Dundee
Paul W Franks, PhD
principal investigator · Lund University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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