Chronic Kidney Disease, Diabetes Mellitus, Type 2, Diabetic Nephropathy
Conditions
Keywords
Glycemic Control, Glycated Hemoglobin, Genes, Transcriptome
Brief 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.
Interventions
OTHERClinical 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.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control (% HbA1c) | At baseline (single cross-sectional assessment). | Proportion of participants with poor glycemic control, defined as HbA1c \> 7%. |
| Diabetic Nephropathy (eGFR) | At baseline (single cross-sectional assessment). | Presence of diabetic nephropathy defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m². |
Countries
Mexico
Outcome results
None listed