Diabetes Research on Patient Stratification (DIRECT)
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ClinicalTrials.gov Identifier: NCT03814915 |
Recruitment Status :
Completed
First Posted : January 24, 2019
Last Update Posted : January 18, 2020
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Condition or disease |
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Type2 Diabetes |
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 |

Group/Cohort |
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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.
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- 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

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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 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:
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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

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
Principal Investigator: | Ewan Pearson, FRCP | University of Dundee | |
Principal Investigator: | Paul W Franks, PhD | Lund University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gene-environment interaction Genome Glycaemic control Lifestyle |
Microbiome Prediabetes Proteome Type 2 diabetes |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |