An observational study in Type 2 Diabetes Mellitus (T2DM) and Hypertension (HTN), sponsored by Coordinación de Investigación en Salud, Mexico. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Coordinación de Investigación en Salud, Mexico · Observational
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Coordinación de Investigación en Salud, Mexico is the lead sponsor of 98 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 to 65 years receiving care at primary health care units of the Mexican Social Security Institute (IMSS) and IMSS-Bienestar in Mexico. Participants do not have a prior diagnosis of type 2 diabetes mellitus or hypertension at baseline and represent a population at risk for developing these conditions. The study includes individuals with varying cardiometabolic profiles, lifestyle behaviors, physical fitness levels, and social and environmental exposures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Incidence of Type 2 Diabetes Mellitus
New cases of type 2 diabetes mellitus identified during follow-up based on clinical diagnosis, laboratory criteria (fasting glucose or HbA1c), or medical records.
Time frame: Up to 5 years
Incidence of Hypertension
New cases of hypertension identified during follow-up based on blood pressure measurements, clinical diagnosis, or medical records.
Time frame: Up to 5 years
Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension
Assessment of dietary quality and its association with the development of metabolic outcomes during follow-up.
Time frame: Up to 5 years
Association Between Changes in Body Weight, Body Composition, and Dyslipidemia With Incident Type 2 Diabetes Mellitus and Hypertension
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.
Time frame: Up to 5 years
Association Between Physical Activity Level and Sedentary Behavior With Incident Type 2 Diabetes Mellitus and Hypertension
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.
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
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.
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
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.
Time frame: Up to 5 years
Time to Development of Type 2 Diabetes Mellitus in Participants With Prediabetes at Baseline
Time from baseline to diagnosis of type 2 diabetes mellitus among participants with prediabetes, based on standard clinical criteria during the follow-up period.
Time frame: Up to 5 years
Time to Development of Hypertension in Participants With Prehypertension at Baseline
Time from baseline to diagnosis of hypertension among participants with prehypertension, based on standard clinical criteria during the follow-up period.
Time frame: Up to 5 years
Latent Structures of Social and Environmental Determinants and Their Association With Incident Type 2 Diabetes Mellitus and Hypertension
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.
Time frame: Up to 5 years
Plan to share: Undecided — The decision to share individual participant data (IPD) has not yet been finalized. Data sharing will be evaluated in accordance with institutional policies of the Mexican Social Security Institute (IMSS), applicable regulations on personal data protection, and ethical considerations. Any future data sharing will ensure confidentiality and appropriate use of de-identified information.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Coordinación de Investigación en Salud, Mexico