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

12 avril 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

1200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Bogdan Vlacho, PharmD
  • Numéro de téléphone: +34 93 207 37 60
  • E-mail: bvlacho@santpau.cat

Lieux d'étude

  • Espagne
    • Catalunya
      • Barcelona, Catalunya, Espagne, 08025
        • Pas encore de recrutement
        • Hospital of Santa Creu i Sant Pau
        • Contact:
          • Didac Mauricio, MD, PhD
      • Barcelona, Catalunya, Espagne, 08025
        • Recrutement
        • Institut Català de la Salut
        • Contact:
          • Josep Franch-Nadal, MD,PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
clusters of type 2 diabetes
Délai: at inclusion
To assess and characterize the relevant subgroups (clusters) of type 2 diabetes at diagnosis in our population
at inclusion

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
gender clinical characteristics
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

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

Collaborateurs

Institut Català de la Salut

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 mars 2022

Achèvement primaire (Anticipé)

31 décembre 2024

Achèvement de l'étude (Anticipé)

31 décembre 2025

Dates d'inscription aux études

Première soumission

28 mars 2022

Première soumission répondant aux critères de contrôle qualité

12 avril 2022

Première publication (Réel)

19 avril 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 avril 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 avril 2022

Dernière vérification

1 avril 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IIBSP-CDM- 2021-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

individual participant data are confidential and will not be shared

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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