Clinical trial NCT03814915: Diabetes Research on Patient Stratification
Official title: DIabetes REsearCh on Patient straTification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Keywords: Gene-environment interaction
Genome
Glycaemic control
Lifestyle
Microbiome
Prediabetes
Proteome
Type 2 diabetes
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 3049
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: White European (self-report of parental ethnicity), Age ≥35 and \<75 years

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).

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

Primary outcomes:
measure: Glycemic deterioration
timeFrame: Up to 10 years follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Dundee
name: Ewan Pearson, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Paul W Franks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.