Type 2 Diabetes and Associated Factors in Mexico

NCT07248891 | Enrolling By Invitation DMC

• 1 other identifier: R-2024-785-007
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Glycemic Control; Glycated Hemoglobin; Genes; Transcriptome

Outcome Measures

Primary Outcomes (2)

• Glycemic control (% HbA1c)

  Proportion of participants with poor glycemic control, defined as HbA1c \> 7%.

  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.

  At baseline (single cross-sectional assessment).

Study Arms (1)

Adults with Type 2 Diabetes

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

Interventions

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.

Adults with Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (3)

Coordinación de Investigación en Salud

Mexico City, Mexico City, 06720, Mexico

Location

División de Investigación en Salud

Mexico City, Mexico City, 06720, Mexico

Location

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (3)

• Francisco V, Pino J, Gonzalez-Gay MA, Mera A, Lago F, Gomez R, Mobasheri A, Gualillo O. Adipokines and inflammation: is it a question of weight? Br J Pharmacol. 2018 May;175(10):1569-1579. doi: 10.1111/bph.14181. Epub 2018 Apr 10.

  PMID: 29486050 BACKGROUND

• Basto-Abreu A, Lopez-Olmedo N, Rojas-Martinez R, Aguilar-Salinas CA, Moreno-Banda GL, Carnalla M, Rivera JA, Romero-Martinez M, Barquera S, Barrientos-Gutierrez T. Prevalencia de prediabetes y diabetes en Mexico: Ensanut 2022. Salud Publica Mex. 2023 Jun 13;65:s163-s168. doi: 10.21149/14832. Spanish.

  PMID: 38060942 RESULT

• Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.

  PMID: 31806905 RESULT

Related Links

• Revista Médica del Instituto Mexicano del Seguro Social

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected for serum and RNA. A 6 mL vacutainer tube was centrifuged to obtain serum for biochemical analysis and complete blood count. RNA was isolated from blood using standard extraction kits for transcriptomic analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Aldo Ferreira Hermosillo, Researcher

  Medical Research Unit in Endocrine Diseases

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

ME (3)