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NCT Number: NCT07577063

Cohort Study of Metabolic Disease and Hypertension

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Hypertension (HTN) Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Prehypertension Signs and Symptoms Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

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 outcomes

  1. Incidence of Type 2 Diabetes Mellitus

    Time frame: Up to 5 years

    New cases of type 2 diabetes mellitus identified during follow-up based on clinical diagnosis, laboratory criteria (fasting glucose or HbA1c), or medical records.

  2. Incidence of Hypertension

    Time frame: Up to 5 years

    New cases of hypertension identified during follow-up based on blood pressure measurements, clinical diagnosis, or medical records.

Secondary outcomes

  1. Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension

    Time frame: Up to 5 years

    Assessment of dietary quality and its association with the development of metabolic outcomes during follow-up.

  2. Association Between Changes in Body Weight, Body Composition, and Dyslipidemia With Incident Type 2 Diabetes Mellitus and Hypertension

    Time frame: Up to 5 years

    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.

  3. Association Between Physical Activity Level and Sedentary Behavior With Incident Type 2 Diabetes Mellitus and Hypertension

    Time frame: Up to 5 years

    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.

  4. 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

    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.

  5. 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

    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.

  6. Time to Development of Type 2 Diabetes Mellitus in Participants With Prediabetes at Baseline

    Time frame: Up to 5 years

    Time from baseline to diagnosis of type 2 diabetes mellitus among participants with prediabetes, based on standard clinical criteria during the follow-up period.

  7. Time to Development of Hypertension in Participants With Prehypertension at Baseline

    Time frame: Up to 5 years

    Time from baseline to diagnosis of hypertension among participants with prehypertension, based on standard clinical criteria during the follow-up period.

  8. Latent Structures of Social and Environmental Determinants and Their Association With Incident Type 2 Diabetes Mellitus and Hypertension

    Time frame: Up to 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rodolfo Rivas Ruiz, PhD

CONTACT

[email protected]

+52 5556276900 ext. 21264

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Instituto Mexicano del Seguro Social
  • Secretaria de Salud, Mexico

Registry information

Official study title

Metabolic Disease and Hypertension in Adults: A Prospective Cohort Study (Phase One)

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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