Type 2 Diabetes and Associated Factors in Mexico

November 26, 2025 updated by: Coordinación de Investigación en Salud, Mexico

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:

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06720
        • Coordinación de Investigación en Salud
      • Mexico City, Mexico City, Mexico, 06720
        • División de Investigación en Salud
      • Mexico City, Mexico City, Mexico, 06720
        • Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Clinical and Molecular Assessment
Participants underwent clinical examination, lifestyle and dietary questionnaires, functional testing (six-minute walk test), and blood sampling for biochemical and transcriptomic analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control (% HbA1c)
Time Frame: At baseline (single cross-sectional assessment).
Proportion of participants with poor glycemic control, defined as HbA1c > 7%.
At baseline (single cross-sectional assessment).
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.
At baseline (single cross-sectional assessment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Study Director: Aldo Ferreira Hermosillo, Researcher, Medical Research Unit in Endocrine Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2024-785-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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