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Diabetes Research on Patient Stratification (DIRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814915
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Lund University

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).

Condition or disease
Type2 Diabetes

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).

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Study Type : Observational
Actual Enrollment : 3049 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DIabetes REsearCh on Patient straTification
Actual Study Start Date : October 15, 2012
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Glycemic deterioration [ Time Frame: Up to 10 years follow-up ]
    Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin


Biospecimen Retention:   Samples With DNA

Blood Omics: Fasting blood samples taken for genomic, transcriptomic, proteomic and metabolomic assessments.

Microbiome Urine Toenail clippings



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
White European (self-report of parental ethnicity), Age ≥35 and <75 years
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814915


Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Ewan Pearson, FRCP University of Dundee
Principal Investigator: Paul W Franks, PhD Lund University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03814915    
Other Study ID Numbers: IMIDIRECT_2012
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
Gene-environment interaction
Genome
Glycaemic control
Lifestyle
Microbiome
Prediabetes
Proteome
Type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases