Diabetes Mellitus, Type 2NCT07248891
Type 2 Diabetes and Associated Factors in Mexico
An observational study of Diabetes Mellitus, Type 2 and Chronic Kidney Disease, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
Trial summary
The goal of this observational cross-sectional multicenter study is to identify clinical, lifestyle, metabolic, inflammatory, and genetic factors associated with glycemic control and complications of Type 2 Diabetes (T2D) in adult patients in Mexico. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Chronic Kidney Disease, Diabetic Nephropathy
- What is being tested?
- Clinical and Molecular Assessment
- How many people
- 1,000 participants
- Where
- 3 sitesMexico
- Study dates
- 1 Apr 2025to 30 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with Type 2 Diabetes Mellitus are recruited from three Family Medicine Units of the Mexican Social Security Institute (IMSS): FMU No. 10 in Coahuila, FMU No. 181 in Jalisco, and FMU No. 30 in Veracruz. The study population represents individuals receiving primary care for diabetes management in different regions of Mexico.
Who may be able to join
- Adults 18 years of age or older.
- Established diagnosis of Type 2 Diabetes Mellitus (T2D).
- Patients receiving care at Family Medicine Units in Coahuila, Jalisco, or Veracruz.
- Willingness to voluntarily participate in the study.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Pregnant or lactating mother
- Current use of steroids
- Concomitant illness with inflammatory or autoimmune component (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, psoriatic arthritis, gout).
- Tobacco use (in the last 3 months).
- History of cerebrovascular disease, heart failure or kidney failure that required hospitalization in the previous month.
- History of infection in the previous 10 days (respiratory tract infection, gastroenteritis, urinary tract infection, soft tissue infection).
- Severe obesity with BMI > 40 kg/m2. History of bariatric surgery.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico3 sites
Coordinación de Investigación en Salud
Mexico City, Mexico City, 06720
División de Investigación en Salud
Mexico City, Mexico City, 06720
Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06720
About this study
Official title: Comprehensive Study of Associated Factors With Type 2 Diabetes in Mexico: Protocol
The goal of this observational cross-sectional multicenter study is to identify clinical, lifestyle, metabolic, inflammatory, and genetic factors associated with glycemic control and complications of Type 2 Diabetes (T2D) in adult patients in Mexico.
The main questions it aims to answer are:
Read more
Which molecular and clinical factors are associated with poor glycemic control (HbA1c > 7%)?
Which factors are linked to the presence of diabetic nephropathy (GFR < 60 mL/min/1.73 m²)?
Participants:
Provide informed consent and clinical history.
Undergo a clinical and physical evaluation (including six-minute walk test).
Complete lifestyle, dietary, and therapeutic adherence questionnaires.
Provide blood samples for biochemical, inflammatory, and transcriptomic (RNA-Seq) analysis.
Researchers integrate clinical, biochemical, and transcriptomic data using statistical modeling to identify a characteristic molecular fingerprint of poor metabolic control and diabetes-related complications.
Read the detailed description
This observational, cross-sectional, multicenter study evaluates adult patients with Type 2 Diabetes (T2D) in three regions of Mexico (Coahuila, Jalisco, and Veracruz) to explore the interaction of clinical, lifestyle, metabolic, inflammatory, and genetic factors with glycemic control and diabetes-related complications. A total of 1,000 participants are recruited from Family Medicine Units, where they undergo standardized clinical assessments, lifestyle and dietary evaluations, functional testing, and laboratory investigations.
Blood samples are collected for biochemical parameters, inflammatory markers, and transcriptomic (RNA-Seq) analysis. Glycemic control is assessed through HbA1c, while diabetic nephropathy is determined using estimated glomerular filtration rate (eGFR). Multivariate and principal component analyses are applied to integrate clinical, biochemical, and molecular information.
The study aims to identify a pathological molecular fingerprint that characterizes poor metabolic control and diabetic complications. By combining clinical and molecular profiles, this protocol seeks to contribute evidence for improving risk stratification, clinical decision-making, and future public health strategies targeting T2D in Mexico.
- Being tested
- Clinical and Molecular Assessment
- Keywords
- Glycemic Control, Glycated Hemoglobin, Genes, Transcriptome
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Molecular AssessmentOther
Participants underwent clinical examination, lifestyle and dietary questionnaires, functional testing (six-minute walk test), and blood sampling for biochemical and transcriptomic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Type 2 Diabetes | This cohort included adult patients (≥18 years) with a confirmed diagnosis of Type 2 Diabetes Mellitus. Participants were recruited from Family Medicine Units in Coahuila, Jalisco, and Veracruz, Mexico. All underwent clinical evaluation, lifestyle and dietary assessments, functional testing, and blood sampling for biochemical and transcriptomic analysis Receives: Other: Clinical and Molecular Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control (% HbA1c)
Proportion of participants with poor glycemic control, defined as HbA1c > 7%.
Measured: At baseline (single cross-sectional assessment).
Diabetic Nephropathy (eGFR)
Presence of diabetic nephropathy defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
Measured: At baseline (single cross-sectional assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Apr 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aldo Ferreira Hermosillo, Researcher, Study director, Medical Research Unit in Endocrine Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248891
- Sponsor's protocol ID
- R-2024-785-007
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, the plan to share individual participant data (IPD) is undecided. The investigators are considering whether de-identified clinical and molecular data can be shared with other researchers while ensuring compliance with IMSS institutional policies, national regulations, and participant privacy protection.
Publications
Francisco V, Pino J, Gonzalez-Gay MA, Mera A, Lago F, Gomez R, Mobasheri A, Gualillo O. Adipokines and inflammation: is it a question of weight? Br J Pharmacol. 2018 May;175(10):1569-1579. doi: 10.1111/bph.14181. Epub 2018 Apr 10.
PubMed 29486050Basto-Abreu A, Lopez-Olmedo N, Rojas-Martinez R, Aguilar-Salinas CA, Moreno-Banda GL, Carnalla M, Rivera JA, Romero-Martinez M, Barquera S, Barrientos-Gutierrez T. Prevalencia de prediabetes y diabetes en Mexico: Ensanut 2022. Salud Publica Mex. 2023 Jun 13;65:s163-s168. doi: 10.21149/14832. Spanish.
PubMed 38060942Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.
PubMed 31806905
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Study of Associated Factors With Type 2 Diabetes in Mexico: Protocol
- ClinicalTrials.gov ID
- NCT07248891
- Acronym / sponsor ID
- R-2024-785-007
- Keywords
- Glycemic Control, Glycated Hemoglobin, Genes, Transcriptome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Nov 2025 (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.
The goal of this observational cross-sectional multicenter study is to identify clinical, lifestyle, metabolic, inflammatory, and genetic factors associated with glycemic control and complications of Type 2 Diabetes (T2D) in adult patients in Mexico.
The main questions it aims to answer are:
Which molecular and clinical factors are associated with poor glycemic control (HbA1c > 7%)?
Which factors are linked to the presence of diabetic nephropathy (GFR < 60 mL/min/1.73 m²)?
Participants:
Provide informed consent and clinical history.
Undergo a clinical and physical evaluation (including six-minute walk test).
Complete lifestyle, dietary, and therapeutic adherence questionnaires.
Provide blood samples for biochemical, inflammatory, and transcriptomic (RNA-Seq) analysis.
Researchers integrate clinical, biochemical, and transcriptomic data using statistical modeling to identify a characteristic molecular fingerprint of poor metabolic control and diabetes-related complications.
Detailed description
This observational, cross-sectional, multicenter study evaluates adult patients with Type 2 Diabetes (T2D) in three regions of Mexico (Coahuila, Jalisco, and Veracruz) to explore the interaction of clinical, lifestyle, metabolic, inflammatory, and genetic factors with glycemic control and diabetes-related complications. A total of 1,000 participants are recruited from Family Medicine Units, where they undergo standardized clinical assessments, lifestyle and dietary evaluations, functional testing, and laboratory investigations.
Blood samples are collected for biochemical parameters, inflammatory markers, and transcriptomic (RNA-Seq) analysis. Glycemic control is assessed through HbA1c, while diabetic nephropathy is determined using estimated glomerular filtration rate (eGFR). Multivariate and principal component analyses are applied to integrate clinical, biochemical, and molecular information.
The study aims to identify a pathological molecular fingerprint that characterizes poor metabolic control and diabetic complications. By combining clinical and molecular profiles, this protocol seeks to contribute evidence for improving risk stratification, clinical decision-making, and future public health strategies targeting T2D in Mexico.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Type 2 Diabetes | – | Other: Clinical and Molecular AssessmentThis cohort included adult patients (≥18 years) with a confirmed diagnosis of Type 2 Diabetes Mellitus. Participants were recruited from Family Medicine Units in Coahuila, Jalisco, and Veracruz, Mexico. All underwent clinical evaluation, lifestyle and dietary assessments, functional testing, and blood sampling for biochemical and transcriptomic analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Type 2 Diabetes Mellitus are recruited from three Family Medicine Units of the Mexican Social Security Institute (IMSS): FMU No. 10 in Coahuila, FMU No. 181 in Jalisco, and FMU No. 30 in Veracruz. The study population represents individuals receiving primary care for diabetes management in different regions of Mexico.
Key inclusion criteria (5 listed)
- Adults 18 years of age or older.
- Established diagnosis of Type 2 Diabetes Mellitus (T2D).
- Patients receiving care at Family Medicine Units in Coahuila, Jalisco, or Veracruz.
- Willingness to voluntarily participate in the study.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (7 listed)
- Pregnant or lactating mother
- Current use of steroids
- Concomitant illness with inflammatory or autoimmune component (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, psoriatic arthritis, gout).
- Tobacco use (in the last 3 months).
- History of cerebrovascular disease, heart failure or kidney failure that required hospitalization in the previous month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Molecular AssessmentParticipants underwent clinical examination, lifestyle and dietary questionnaires, functional testing (six-minute walk test), and blood sampling for biochemical and transcriptomic analysis. | Other | Adults with Type 2 Diabetes |
Primary outcome
Glycemic control (% HbA1c)
Time frame: At baseline (single cross-sectional assessment).
Proportion of participants with poor glycemic control, defined as HbA1c > 7%.
Diabetic Nephropathy (eGFR)
Time frame: At baseline (single cross-sectional assessment).
Presence of diabetic nephropathy defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 29486050Francisco V, Pino J, Gonzalez-Gay MA, Mera A, Lago F, Gomez R, Mobasheri A, Gualillo O. Adipokines and inflammation: is it a question of weight? Br J Pharmacol. 2018 May;175(10):1569-1579. doi: 10.1111/bph.14181. Epub 2018 Apr 10.
- Results publication: PubMed 38060942Basto-Abreu A, Lopez-Olmedo N, Rojas-Martinez R, Aguilar-Salinas CA, Moreno-Banda GL, Carnalla M, Rivera JA, Romero-Martinez M, Barquera S, Barrientos-Gutierrez T. Prevalencia de prediabetes y diabetes en Mexico: Ensanut 2022. Salud Publica Mex. 2023 Jun 13;65:s163-s168. doi: 10.21149/14832. Spanish.
- Results publication: PubMed 31806905Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.
- Revista Médica del Instituto Mexicano del Seguro SocialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this time, the plan to share individual participant data (IPD) is undecided. The investigators are considering whether de-identified clinical and molecular data can be shared with other researchers while ensuring compliance with IMSS institutional policies, national regulations, and participant privacy protection.
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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.
Aldo Ferreira Hermosillo, Researcher study director
Medical Research Unit in Endocrine Diseases
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Chronic Kidney Disease, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (% HbA1c) (time frame: At baseline (single cross-sectional assessment).). The study lists 2 primary outcomes in all. 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 NCT07248891, which also lists 3 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 4 Dec 2025.