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Characterization of Type 2 Diabetes Subgroups at Diagnosis: a Necessary Step Towards Precision Medicine in Diabetes. (COPERNICAN)

12. april 2022 oppdatert av: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Caracterización de Subgrupos de Diabetes Tipo 2 al diagnóstico: un Paso Necesario Hacia la Medicina de precisión en Diabetes.

Objectives: The primary objective is to identify and characterize the relevant subgroups ( clusters ) in type 2 diabetes (T2DM) at the time of diagnosis in our region. This objective will be addressed using the six main variables (see Methodology) used so far in previous studies in other populations to develop the clustering of diabetes. Therefore, this is a study in diagnostic precision medicine in diabetes. In addition, as secondary objectives, other phenotypic characteristics of these subgroups (clinical, metabolic, and associated comorbidities) will be evaluated.

Methodology: This project will establish a prospective observational cohort study of 1200 subjects newly diagnosed with T2DM in primary care centers in the healthcare areas of Barcelona city and the territory of Lleida. All newly diagnosed cases of T2DM will be identified and evaluated. Participants will undergo a comprehensive phenotypic evaluation, including the six variables that will allow the characterization of T2DM subgroups: age, antibodies against glutamic acid decarboxylase (GAD), body mass index, glycated hemoglobin, and sensitivity indices ( HOMA-IR) and insulin secretion (HOMA beta), based on the determination of C-peptide. The latest generation cluster analysis (k- means and hierarchical clustering ) will be performed, following the method described in previous studies using the six variables mentioned above. Onset diabetes subgroups and their association with secondary outcome variables will be assessed. The initial prescription of antidiabetic medication will be evaluated. Other procedures of this project include: clinical (including complications) and biochemical evaluation, advanced lipoprotein profile, and validated questionnaires to evaluate diet and physical activity.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

A multicenter prospective observational study will be conducted. The study design contemplates a single visit that will coincide with the inclusion of the patient in the study. Prior to the inclusion visit, a pre-selection period is planned in which the possible candidate will be invited, all the study procedures will be explained and clarified, the selection criteria will be checked and the inclusion visit will be scheduled.

The scope of the study is made up of Primary Care Centers (CAP) in 2 large health areas (Barcelona and Lleida). In the Annex 8 section, the characteristics and expected recruitment capacity of each CAP are detailed. We have taken a conservative approach using the lower range of incidence calculated based on our own data from 2019 to 2020. The table provided used an expected acceptance rate for participation of 80%. Additionally, CAPs were selected based on commitment and performance in our previous studies. It is planned to include 1200 participants newly diagnosed with T2DM. Depending on compliance with the recruitment rate, the inclusion of other CAPs is possible to achieve the expected number of participants in the study.

Follow-up of participants and linkage with other databases

For this study, a pragmatic follow-up of the participants will be chosen, which is adapted to the usual clinical practice for the follow-up of diabetes. For this reason, the monitoring will be done from:

  • SIDIAP/PADRIS databases, with the link to the electronic medical record of the participants who have accepted this option in the informed consent.
  • Electronic medical record, in the event that the link with the SIDIAP/PADRIS databases is not possible for technical reasons (non-ICS centers), the collection of monitoring variables will be done directly from the clinical course (review of clinical history) of participants without scheduling additional study follow-up visits.
  • For specific causes of mortality, data linkage with the National Institute of Statistics (INE) will be used.
  • If the participants have already participated or are participating in other clinical research studies and want to transfer the data they have provided for other projects to this study, this linking (portability) of the data will be allowed.

All participants will be followed until the end of the study, death or withdrawal of informed consent.

Studietype

Observasjonsmessig

Registrering (Forventet)

1200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Spania
    • Catalunya
      • Barcelona, Catalunya, Spania, 08025
        • Har ikke rekruttert ennå
        • Hospital of Santa Creu i Sant Pau
        • Ta kontakt med:
          • Didac Mauricio, MD, PhD
      • Barcelona, Catalunya, Spania, 08025
        • Rekruttering
        • Institut Català de la Salut
        • Ta kontakt med:
          • Josep Franch-Nadal, MD,PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

People with type 2 diabetes mellitus treated in primary care centers in Barcelona and Lleida.

Beskrivelse

Inclusion Criteria:

  • Subjects of both sexes, of legal age (≥18 years)
  • Newly diagnosed T2DM according to the criteria of the American Diabetes Association
  • With a maximum duration of three months of the disease at the time of inclusion.
  • Writen informed consent

Exclusion Criteria:

Subjects with a new diagnosis of other types of diabetes (type 1, MODY, gestational or other causes) will also be evaluated to ensure that the diagnostic criteria for selection are correctly implemented in all potential study participants.

*For final analysis, subjects with any diagnosis of diabetes other than T2DM will be excluded from the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Newly diagnosed T2DM

To assess and characterize the relevant subgroups (clusters) of type 2 diabetes at diagnosis in our population.

This objective will be addressed using the 6 main variables that have been used so far in previous studies in other populations to develop disease groupings, that is, age, GAD antibodies, body mass index, glycosylated hemoglobin (HbA1c), and estimates of the evaluation of the homeostatic model 2 of β-cell function and insulin resistance.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
clusters of type 2 diabetes
Tidsramme: at inclusion
To assess and characterize the relevant subgroups (clusters) of type 2 diabetes at diagnosis in our population
at inclusion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
gender clinical characteristics
Tidsramme: at inclusion
To assess if there are gender diferences among the type 2 diabetes persons at diagnosis
at inclusion
Frequency of various associated comorbidities, including micro and macrovascular complications
Tidsramme: 24 month follow-up period
To evaluate and describe the complications of type 2 diabetes during the 24 month follow-up period
24 month follow-up period
Advanced lipoprotein profile
Tidsramme: at inclusion
to explore and characterize the lipoprotein profile of the persons with type 2 diabetes at diagnosis
at inclusion
Lifestyle variables: eating habits and physical activity
Tidsramme: at inclusion
to explore if there are differences in lifestyle variables such as eating habits and physical activity at diagnosis of type 2 Diabetes Mellitus
at inclusion
Use in real clinical practice of antidiabetics and other treatments at the beginning of the disease
Tidsramme: at inclusion
to explore if there are differences in treatment of the antidiabetic drugs and other concomitant medications at diagnosis of type 2 Diabetes Mellitus
at inclusion
Appearance of different micro- and macro-vascular complications of diabetes
Tidsramme: 24 month follow-up period
to explore if there are differences in micro and macrovascular complications during the follow-up period related to different sub-types of type 2 Diabetes Mellitus
24 month follow-up period
Metabolomics and genetic profile related to diabetes
Tidsramme: at inclusion
to explore if there are differences in Metabolomics and genetic profile related to different sub-types of type 2 Diabetes Mellitus at diagnosis
at inclusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Samarbeidspartnere

Institut Català de la Salut

Etterforskere

  • Hovedetterforsker: Dídac Mauricio, MD, PhD, Hospital of Santa Creu i Sant Pau

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mars 2022

Primær fullføring (Forventet)

31. desember 2024

Studiet fullført (Forventet)

31. desember 2025

Datoer for studieregistrering

Først innsendt

28. mars 2022

Først innsendt som oppfylte QC-kriteriene

12. april 2022

Først lagt ut (Faktiske)

19. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIBSP-CDM- 2021-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

individual participant data are confidential and will not be shared

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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