Type 2 Diabetes Mellitus (T2DM)NCT07577063
Cohort Study of Metabolic Disease and Hypertension
An observational study of Type 2 Diabetes Mellitus (T2DM) and Hypertension (HTN), run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Hypertension (HTN)
- What is being tested?
- Observational Study
- How many people
- 2,500 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2026to Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06720
Rodolfo Rivas Ruiz, PhD, 5556276900 ext. 21264, rodolfo.rivasr@imss.gob.mx
Ivonne Roy García, PhD, 5556276900 ext. 21264, ivonne3316@gmail.com
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Observational Study
- Keywords
- Type 2 Diabetes Mellitus, Hypertension, Cardiometabolic risk, Obesity, Prediabetes, Prehypertension
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Obesity, Prediabetic State, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
Participants are observed over time without receiving any experimental intervention. Data are collected as part of routine clinical assessments and scheduled follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Secretaria de Salud, Mexico, Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
- Investigators
- Rodolfo Rivas, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577063
- Sponsor's protocol ID
- R-2026-785-027
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Disease and Hypertension in Adults: A Prospective Cohort Study (Phase One)
- ClinicalTrials.gov ID
- NCT07577063
- Acronym / sponsor ID
- R-2026-785-027
- Keywords
- Type 2 Diabetes Mellitus, Hypertension, Cardiometabolic risk, Obesity, Prediabetes, Prehypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Secretaria de Salud, Mexico, Instituto Mexicano del Seguro Social
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General population cohort | – | Other: Observational StudyThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyParticipants are observed over time without receiving any experimental intervention. Data are collected as part of routine clinical assessments and scheduled follow-up visits. | Other | General population cohort |
Primary outcome
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodolfo Rivas, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Hypertension (HTN), run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodolfo Rivas Ruiz, PhD (+52 5556276900 ext. 21264, rodolfo.rivasr@imss.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Type 2 Diabetes Mellitus (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.