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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Coordinación de Investigación en Salud, Mexico is the lead sponsor of 98 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
No contact was published for this record. The registry link below has the sponsor’s details.
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Coordinación de Investigación en Salud, Mexico