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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital of Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Institut Català de la Salut
RECRUITING
Barcelona
Contact Information
Primary
Dídac Mauricio, MD, PhD
dmauricio@santpau.cat
+34935565661
Backup
Bogdan Vlacho, PharmD
bvlacho@santpau.cat
+34 93 207 37 60
Time Frame
Start Date: 2022-03-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Institut Català de la Salut

This content was sourced from clinicaltrials.gov