Type 2 Diabetes and Associated Factors in Mexico

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus, Type 2 Chronic Disease Chronic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Nephropathy Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coordinación de Investigación en Salud, Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical and Molecular Assessment

Other

Participants underwent clinical examination, lifestyle and dietary questionnaires, functional testing (six-minute walk test), and blood sampling for biochemical and transcriptomic analysis.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Nov 25, 2025
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed