Type 2 Diabetes and Associated Factors in Mexico

Coordinación de Investigación en Salud, Mexico

Status: Invitation-only

Conditions: Diabetic Nephropathy; Chronic Kidney Disease; Diabetes Mellitus, Type 2

Treatments: Other: Clinical and Molecular Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07248891

R-2024-785-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Adults with Type 2 Diabetes

Description:

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

Treatment:

Other: Clinical and Molecular Assessment