Cohort Study of Metabolic Disease and Hypertension

NCT07577063 | Not Yet Recruiting

• 1 other identifier: R-2026-785-027
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Hypertension (HTN)

Keywords

Type 2 Diabetes Mellitus; Hypertension; Cardiometabolic risk; Obesity; Prediabetes; Prehypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 5 years

Secondary Outcomes (8)

• Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension

  Up to 5 years

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

  Up to 5 years

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

  Up to 5 years

• Association Between Physical Fitness Measured by the Six-Minute Walk Test and Incident Type 2 Diabetes Mellitus and Hypertension

  Up to 5 years

• Association Between Family History of Type 2 Diabetes Mellitus and Hypertension and Incident Type 2 Diabetes Mellitus and Hypertension

  Up to 5 years

Study Arms (1)

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.

Other: Observational Study

Interventions

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.

General population cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Secretaria de Salud, Mexico: collaborator
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Obesity; Prediabetic State; Prehypertension

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Rodolfo Rivas, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodolfo Rivas Ruiz, PhD

CONTACT

+52 5556276900; rodolfo.rivasr@imss.gob.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

ME (1)