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

NCT05333718 | Unknown

• 1 other identifier: IIBSP-CDM- 2021-01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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

Characteristics Disease; Type 2 Diabetes

Keywords

primary care centers; clusters

Outcome Measures

Primary Outcomes (1)

• clusters of type 2 diabetes

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

  at inclusion

Secondary Outcomes (7)

• gender clinical characteristics

  at inclusion

• Frequency of various associated comorbidities, including micro and macrovascular complications

  24 month follow-up period

• Advanced lipoprotein profile

  at inclusion

• Lifestyle variables: eating habits and physical activity

  at inclusion

• Use in real clinical practice of antidiabetics and other treatments at the beginning of the disease

  at inclusion

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subjects of both sexes, of legal age (≥18 years)
• Newly diagnosed T2DM according to the criteria of the American Diabetes Association
• Writen informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Institut Català de la Salut: collaborator

Study Sites (2)

Hospital of Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

NOT YET RECRUITING

Institut Català de la Salut

Barcelona, Catalonia, 08025, Spain

RECRUITING

Related Publications (1)

• Fernandez-Camins B, Vlacho B, Canudas A, Ortega M, Granado-Casas M, Perera-LLuna A, Boluda-Sanson A, El-Khattabi-Ofkir Y, Franch-Nadal J, Mauricio D; COPERNICAN Research Group. Characterisation of type 2 diabetes subgroups at diagnosis: the COPERNICAN prospective observational cohort study protocol. BMJ Open. 2024 Dec 15;14(12):e083825. doi: 10.1136/bmjopen-2023-083825.

  PMID: 39675821 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dídac Mauricio, MD, PhD

  Hospital of Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dídac Mauricio, MD, PhD

CONTACT

+34935565661; dmauricio@santpau.cat

Bogdan Vlacho, PharmD

CONTACT

+34 93 207 37 60; bvlacho@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 19, 2022
• Study Start: March 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)