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Type2 DiabetesDIRECTNCT03814915

Diabetes Research on Patient Stratification

An observational study of Type2 Diabetes, run by Lund University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 35 to 74 years
Conditions the study is for
Type2 Diabetes
How many people
3,049 participants
Where
No sites listed yet
Study dates
15 Oct 2012to 31 Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
  • 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
Show all 10Show fewer
  • All HbA1c <7.6% (<60 mmol/mol) within previous 3 months
  • White European
  • Age ≥35 and <75
  • Estimated GFR >50 ml/min'

Who cannot join

  • 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
  • Type 1 diabetes
Show all 11Show fewer
  • 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

About this study

Official title: DIabetes REsearCh on Patient straTification

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).

Conditions
Type2 Diabetes
Keywords
Gene-environment interaction, Genome, Glycaemic control, Lifestyle, Microbiome, Prediabetes, Proteome, Type 2 diabetes
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03814915
Study groupRoleWhat they receive
Study 1 - PrediabetesThe 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- DiabeticThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic deterioration

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

    Measured: Up to 10 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start15 Oct 2012
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,049 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03814915
Sponsor's protocol ID
IMIDIRECT_2012
Acronym
DIRECT
Status last verified
Jan 2020
First submitted
21 Jan 2019
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Lyu L, Fan Y, Vogt JK, Clos-Garcia M, Bonnefond A, Pedersen HK, Dutta A, Koivula R, Sharma S, Allin KH, Brorsson C, Cederberg H, Chabanova E, De Masi F, Dermitzakis E, Elders PJ, Blom MT, Hollander M, Eriksen R, Forgie I, Frost G, Giordano GN, Grallert H, Haid M, Hansen TH, Jablonka B, Kokkola T, Mahajan A, Mari A, McDonald TJ, Musholt PB, Pavo I, Prehn C, Ridderstrale M, Ruetten H, Hart LM', Schwenk JM, Stankevic E, Thomsen HS, Vangipurapu J, Vestergaard H, Vinuela A, Walker M, Hansen T, Linneberg A, Nielsen HB, Brunak S, McCarthy MI, Froguel P, Adamski J, Franks PW, Laakso M, Beulens JWJ, Pearson E, Pedersen O. The dynamics of the gut microbiota in prediabetes during a four-year follow-up among European patients-an IMI-DIRECT prospective study. Genome Med. 2025 Jul 15;17(1):78. doi: 10.1186/s13073-025-01508-7.

    PubMed 40665409

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes, run by Lund University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic deterioration (time frame: Up to 10 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03814915, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020; AzTrials last refreshed its copy on 2 Nov 2026.

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