Type 2 Diabetes and Associated Factors in Mexico

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Glycemic control (% HbA1c) [Срок оценки: At baseline (single cross-sectional assessment).]
• Diabetic Nephropathy (eGFR) [Срок оценки: At baseline (single cross-sectional assessment).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Мексика · 3 центра

• Coordinación de Investigación en Salud — Mexico City
• División de Investigación en Salud — Mexico City
• Instituto Mexicano del Seguro Social — Mexico City

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07248891 · R-2024-785-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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