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

NCT05333718 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2022-04-19

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Institut Català de la Salut

    collaborator OTHER

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

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333718 on ClinicalTrials.gov