Cohort Study of Metabolic Disease and Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Study.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Hypertension (HTN). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Metabolic Disease and Hypertension in Adults: A Prospective Cohort Study (Phase One)
Overview
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.
Detailed description
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.
Interventions
- Other Observational Study
Participants are observed over time without receiving any experimental intervention. Data are collected as part of routine clinical assessments and scheduled follow-up visits.
Primary outcome measures
- Incidence of Type 2 Diabetes Mellitus [Time frame: Up to 5 years]
- Incidence of Hypertension [Time frame: Up to 5 years]
Secondary outcome measures (8)
- Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension [Time frame: Up to 5 years]
- Association Between Changes in Body Weight, Body Composition, and Dyslipidemia With Incident Type 2 Diabetes Mellitus and Hypertension [Time frame: Up to 5 years]
- Association Between Physical Activity Level and Sedentary Behavior With Incident Type 2 Diabetes Mellitus and Hypertension [Time frame: Up to 5 years]
- Association Between Physical Fitness Measured by the Six-Minute Walk Test and Incident Type 2 Diabetes Mellitus and Hypertension [Time frame: Up to 5 years]
- Association Between Family History of Type 2 Diabetes Mellitus and Hypertension and Incident Type 2 Diabetes Mellitus and Hypertension [Time frame: Up to 5 years]
- Time to Development of Type 2 Diabetes Mellitus in Participants With Prediabetes at Baseline [Time frame: Up to 5 years]
- Time to Development of Hypertension in Participants With Prehypertension at Baseline [Time frame: Up to 5 years]
- Latent Structures of Social and Environmental Determinants and Their Association With Incident Type 2 Diabetes Mellitus and Hypertension [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Mexico · 1 center
- Instituto Mexicano del Seguro Social — Mexico City
Identifiers
NCT: NCT07577063 · R-2026-785-027