Cohort Study of Metabolic Disease and Hypertension
Metabolic Disease and Hypertension in Adults: A Prospective Cohort Study (Phase One)
The goal of this observational study is to learn how type 2 diabetes and high blood pressure develop over time in adults in Mexico. The study will include men and women between 18 and 65 years of age who do not have a previous diagnosis of these conditions.
The main questions this study aims to answer are:
What factors increase the risk of developing type 2 diabetes? What factors increase the risk of developing high blood pressure?
Participants will not receive any experimental treatment. Researchers will observe their health as part of their regular medical care.
Participants will:
Attend an initial visit that includes physical measurements, blood tests, and questionnaires about their health, lifestyle, and environment Perform a simple walking test to measure physical fitness Return once a year for follow-up visits over a period of five years
During the study, researchers will monitor participants to identify new cases of type 2 diabetes and high blood pressure.
The results of this study may help improve prevention strategies and support public health programs aimed at reducing chronic diseases in Mexico.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This prospective dynamic cohort study includes repeated annual measurements to evaluate temporal changes in cardiometabolic exposures and their relationship with incident outcomes.
Data will be collected using standardized procedures and electronic case report forms captured via a tablet-based system. Information will be recorded in the digital platform of the MIDO ecosystem, developed by the Carlos Slim Health Institute, and subsequently safeguarded by the Mexican Social Security Institute (IMSS) in accordance with applicable regulations on research and personal data protection. The database will be preserved for at least 10 years, ensuring confidentiality and appropriate use of the information.
Measurements include anthropometric assessments, blood pressure, biochemical testing, and structured instruments for lifestyle, physical fitness, and social and environmental determinants. Physical fitness will be assessed using the six-minute walk test.
Data management will include internal consistency checks, identification of outliers, and assessment of missing data. When appropriate, imputation methods and sensitivity analyses will be applied.
Participants will be followed longitudinally, allowing evaluation of changes in exposures and their association with outcomes. Statistical analysis will include multivariable models and dimensionality reduction techniques, such as principal component analysis, to identify patterns among risk factors.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rodolfo Rivas Ruiz, PhD
- Número de teléfono: 21264 +52 5556276900
- Correo electrónico: rodolfo.rivasr@imss.gob.mx
Ubicaciones de estudio
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Mexico City
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Mexico City, Mexico City, México, 06720
- Instituto Mexicano del Seguro Social
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Contacto:
- Rodolfo Rivas Ruiz, PhD
- Número de teléfono: 21264 5556276900
- Correo electrónico: rodolfo.rivasr@imss.gob.mx
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Contacto:
- Ivonne Roy García, PhD
- Número de teléfono: 21264 5556276900
- Correo electrónico: ivonne3316@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged 18 to 65 years
- No prior diagnosis of type 2 diabetes mellitus or hypertension
- Receiving care at primary health care units of the Mexican Social Security Institute (IMSS) or IMSS-Bienestar
- Willing and able to provide informed consent
- Willing to participate in baseline and annual follow-up assessments
Exclusion Criteria:
- Prior diagnosis of type 2 diabetes mellitus or hypertension
- Pregnancy at the time of enrollment
- Any condition that limits the ability to perform study procedures, including the six-minute walk test
- Any condition that, in the opinion of the investigators, may interfere with participation or follow-up
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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General population cohort
This cohort includes adults aged 18 to 65 years without a prior diagnosis of type 2 diabetes mellitus or hypertension, who are followed over time to evaluate the development of these conditions and their association with cardiometabolic, lifestyle, physical fitness, and social and environmental factors.
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Participants are observed over time without receiving any experimental intervention.
Data are collected as part of routine clinical assessments and scheduled follow-up visits.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Type 2 Diabetes Mellitus
Periodo de tiempo: Up to 5 years
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New cases of type 2 diabetes mellitus identified during follow-up based on clinical diagnosis, laboratory criteria (fasting glucose or HbA1c), or medical records.
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Up to 5 years
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Incidence of Hypertension
Periodo de tiempo: Up to 5 years
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New cases of hypertension identified during follow-up based on blood pressure measurements, clinical diagnosis, or medical records.
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Up to 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension
Periodo de tiempo: Up to 5 years
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Assessment of dietary quality and its association with the development of metabolic outcomes during follow-up.
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Up to 5 years
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Association Between Changes in Body Weight, Body Composition, and Dyslipidemia With Incident Type 2 Diabetes Mellitus and Hypertension
Periodo de tiempo: Up to 5 years
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Assessment of the association between longitudinal changes in body weight, body composition, and dyslipidemia and the incidence of type 2 diabetes mellitus and hypertension during the follow-up period.
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Up to 5 years
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Association Between Physical Activity Level and Sedentary Behavior With Incident Type 2 Diabetes Mellitus and Hypertension
Periodo de tiempo: Up to 5 years
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Assessment of the association between physical activity level and sedentary behavior and the incidence of type 2 diabetes mellitus and hypertension during the follow-up period.
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Up to 5 years
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Association Between Physical Fitness Measured by the Six-Minute Walk Test and Incident Type 2 Diabetes Mellitus and Hypertension
Periodo de tiempo: Up to 5 years
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Assessment of the association between physical fitness measured by the six-minute walk test and the incidence of type 2 diabetes mellitus and hypertension during the follow-up period.
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Up to 5 years
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Association Between Family History of Type 2 Diabetes Mellitus and Hypertension and Incident Type 2 Diabetes Mellitus and Hypertension
Periodo de tiempo: Up to 5 years
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Assessment of the association between family history of type 2 diabetes mellitus and hypertension and the incidence of these conditions during the follow-up period.
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Up to 5 years
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Time to Development of Type 2 Diabetes Mellitus in Participants With Prediabetes at Baseline
Periodo de tiempo: Up to 5 years
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Time from baseline to diagnosis of type 2 diabetes mellitus among participants with prediabetes, based on standard clinical criteria during the follow-up period.
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Up to 5 years
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Time to Development of Hypertension in Participants With Prehypertension at Baseline
Periodo de tiempo: Up to 5 years
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Time from baseline to diagnosis of hypertension among participants with prehypertension, based on standard clinical criteria during the follow-up period.
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Up to 5 years
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Latent Structures of Social and Environmental Determinants and Their Association With Incident Type 2 Diabetes Mellitus and Hypertension
Periodo de tiempo: Up to 5 years
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Identification of latent structures of social and environmental determinants using principal component analysis and assessment of their association with the incidence of type 2 diabetes mellitus and hypertension during the follow-up period.
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Up to 5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rodolfo Rivas, PhD, Instituto Mexicano del Seguro Social
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Hipertensión
- Diabetes Mellitus, Tipo 2
- Estado prediabético
- Prehipertensión
- Técnicas de investigación
- Métodos
- Observación
Otros números de identificación del estudio
- R-2026-785-027
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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