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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Rodolfo Rivas Ruiz, PhD
- Número de telefone: 21264 +52 5556276900
- E-mail: rodolfo.rivasr@imss.gob.mx
Locais de estudo
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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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Contato:
- Rodolfo Rivas Ruiz, PhD
- Número de telefone: 21264 5556276900
- E-mail: rodolfo.rivasr@imss.gob.mx
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Contato:
- Ivonne Roy García, PhD
- Número de telefone: 21264 5556276900
- E-mail: ivonne3316@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Type 2 Diabetes Mellitus
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Excesso de peso
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Obesidade
- Hipertensão
- Diabetes Mellitus, Tipo 2
- Estado pré-diabético
- Pré-hipertensão
- Técnicas de investigação
- Métodos
- Observação
Outros números de identificação do estudo
- R-2026-785-027
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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