An observational study in Diabetes Mellitus, Type 2, Chronic Kidney Disease and Diabetic Nephropathy, sponsored by Coordinación de Investigación en Salud, Mexico. Enrolling by invitation at 3 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Coordinación de Investigación en Salud, Mexico · Observational
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.
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.
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.
Exclusion Criteria:
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.
Glycemic control (% HbA1c)
Proportion of participants with poor glycemic control, defined as HbA1c \> 7%.
Time frame: 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.
Time frame: At baseline (single cross-sectional assessment).
Plan to share: 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Coordinación de Investigación en Salud, Mexico