Cohort Study of Metabolic Disease and Hypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCoordinación de Investigación en Salud, Mexico
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Study
Other interventionParticipants are observed over time without receiving any experimental intervention. Data are collected as part of routine clinical assessments and scheduled follow-up visits.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: General population cohort1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Coordinación de Investigación en Salud, Mexico
Lead sponsor
Secretaria de Salud, Mexico
Collaborator
Instituto Mexicano del Seguro Social
Collaborator
Source ClinicalTrials.gov
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