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

12 aprile 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

1200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Spagna
    • Catalunya
      • Barcelona, Catalunya, Spagna, 08025
        • Non ancora reclutamento
        • Hospital of Santa Creu i Sant Pau
        • Contatto:
          • Didac Mauricio, MD, PhD
      • Barcelona, Catalunya, Spagna, 08025
        • Reclutamento
        • Institut Català de la Salut
        • Contatto:
          • Josep Franch-Nadal, MD,PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
clusters of type 2 diabetes
Lasso di tempo: at inclusion
To assess and characterize the relevant subgroups (clusters) of type 2 diabetes at diagnosis in our population
at inclusion

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
gender clinical characteristics
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

Institut Català de la Salut

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 marzo 2022

Completamento primario (Anticipato)

31 dicembre 2024

Completamento dello studio (Anticipato)

31 dicembre 2025

Date di iscrizione allo studio

Primo inviato

28 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

12 aprile 2022

Primo Inserito (Effettivo)

19 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IIBSP-CDM- 2021-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

individual participant data are confidential and will not be shared

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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