Metabolic Disease and Hypertension in Adults: A Prospective Cohort Study (Phase One)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,500
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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