Characteristics DiseaseCOPERNICANNCT05333718
Characterization of Type 2 Diabetes Subgroups at Diagnosis: a Necessary Step Towards Precision Medicine in Diabetes.
An observational study of Characteristics Disease and Type 2 Diabetes, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Characteristics Disease, Type 2 Diabetes
- How many people
- 1,200 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Mar 2022to 31 Dec 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with type 2 diabetes mellitus treated in primary care centers in Barcelona and Lleida.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital of Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
Dídac Mauricio, MD, PhD
- Recruiting
Institut Català de la Salut
Barcelona, Catalonia, 08025
Josep Franch-Nadal, MD,PhD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Characteristics Disease, Type 2 Diabetes
- Keywords
- primary care centers, clusters
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clusters of type 2 diabetes
To assess and characterize the relevant subgroups (clusters) of type 2 diabetes at diagnosis in our population
Measured: at inclusion
Secondary outcomes (7)
gender clinical characteristics
To assess if there are gender diferences among the type 2 diabetes persons at diagnosis
Measured: at inclusion
Frequency of various associated comorbidities, including micro and macrovascular complications
To evaluate and describe the complications of type 2 diabetes during the 24 month follow-up period
Measured: 24 month follow-up period
Advanced lipoprotein profile
to explore and characterize the lipoprotein profile of the persons with type 2 diabetes at diagnosis
Measured: at inclusion
Lifestyle variables: eating habits and physical activity
to explore if there are differences in lifestyle variables such as eating habits and physical activity at diagnosis of type 2 Diabetes Mellitus
Measured: at inclusion
Use in real clinical practice of antidiabetics and other treatments at the beginning of the disease
to explore if there are differences in treatment of the antidiabetic drugs and other concomitant medications at diagnosis of type 2 Diabetes Mellitus
Measured: at inclusion
Appearance of different micro- and macro-vascular complications of diabetes
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
Measured: 24 month follow-up period
Metabolomics and genetic profile related to diabetes
to explore if there are differences in Metabolomics and genetic profile related to different sub-types of type 2 Diabetes Mellitus at diagnosis
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start8 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Characteristics DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
- Investigators
- Dídac Mauricio, MD, PhD, Principal investigator, Hospital of Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333718
- Sponsor's protocol ID
- IIBSP-CDM- 2021-01
- Acronym
- COPERNICAN
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data are confidential and will not be shared
Publications
Fernandez-Camins B, Vlacho B, Rojo-Lopez MI, Granado-Casas M, Gratacos M, Ortega-Bravo M, Cendros-Massioui M, Palmieri F, Perera-LLuna A, Franch-Nadal J, Mauricio D; COPERNICAN Research Group. Phenotypic clustering of newly diagnosed type 2 diabetes in a Mediterranean cohort. Cardiovasc Diabetol. 2026 May 4;25(1):186. doi: 10.1186/s12933-026-03198-w.
PubMed 42083025Fernandez-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.
PubMed 39675821
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caracterización de Subgrupos de Diabetes Tipo 2 al diagnóstico: un Paso Necesario Hacia la Medicina de precisión en Diabetes.
- ClinicalTrials.gov ID
- NCT05333718
- Acronym / sponsor ID
- COPERNICAN / IIBSP-CDM- 2021-01
- Conditions
- Characteristics Disease, Type 2 Diabetes
- Keywords
- primary care centers, clusters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with type 2 diabetes mellitus treated in primary care centers in Barcelona and Lleida.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clusters of type 2 diabetes
Time frame: at inclusion
To assess and characterize the relevant subgroups (clusters) of type 2 diabetes at diagnosis in our population
7 secondary outcomes
gender clinical characteristics
Time frame: at inclusion
Frequency of various associated comorbidities, including micro and macrovascular complications
Time frame: 24 month follow-up period
Advanced lipoprotein profile
Time frame: at inclusion
Lifestyle variables: eating habits and physical activity
Time frame: at inclusion
Use in real clinical practice of antidiabetics and other treatments at the beginning of the disease
Time frame: at inclusion
Appearance of different micro- and macro-vascular complications of diabetes
Time frame: 24 month follow-up period
Metabolomics and genetic profile related to diabetes
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 42083025Fernandez-Camins B, Vlacho B, Rojo-Lopez MI, Granado-Casas M, Gratacos M, Ortega-Bravo M, Cendros-Massioui M, Palmieri F, Perera-LLuna A, Franch-Nadal J, Mauricio D; COPERNICAN Research Group. Phenotypic clustering of newly diagnosed type 2 diabetes in a Mediterranean cohort. Cardiovasc Diabetol. 2026 May 4;25(1):186. doi: 10.1186/s12933-026-03198-w.
- Derived from this study: PubMed 39675821Fernandez-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.
- Individual participant dataSharing planned: No. individual participant data are confidential and will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dídac Mauricio, MD, PhD principal investigator
Hospital of Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Characteristics Disease and Type 2 Diabetes, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dídac Mauricio, MD, PhD (+34935565661, dmauricio@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clusters of type 2 diabetes (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05333718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.