NCT07248891

Type 2 Diabetes and Associated Factors in Mexico

Comprehensive Study of Associated Factors With Type 2 Diabetes in Mexico: Protocol

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Diabetes Mellitus, Type 2
• Chronic Kidney Disease
• Diabetic Nephropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-11-25
• Last updated: 2025-12-04

Locations

3 sites across 1 country: Mexico