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Cohort Study of Metabolic Disease and Hypertension

5. mai 2026 oppdatert av: Coordinación de Investigación en Salud, Mexico

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:

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

2500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06720
        • Instituto Mexicano del Seguro Social
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Type 2 Diabetes Mellitus
Tidsramme: 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.
Up to 5 years
Incidence of Hypertension
Tidsramme: Up to 5 years
New cases of hypertension identified during follow-up based on blood pressure measurements, clinical diagnosis, or medical records.
Up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension
Tidsramme: Up to 5 years
Assessment of dietary quality and its association with the development of metabolic outcomes during follow-up.
Up to 5 years
Association Between Changes in Body Weight, Body Composition, and Dyslipidemia With Incident Type 2 Diabetes Mellitus and Hypertension
Tidsramme: 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.
Up to 5 years
Association Between Physical Activity Level and Sedentary Behavior With Incident Type 2 Diabetes Mellitus and Hypertension
Tidsramme: 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.
Up to 5 years
Association Between Physical Fitness Measured by the Six-Minute Walk Test and Incident Type 2 Diabetes Mellitus and Hypertension
Tidsramme: 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.
Up to 5 years
Association Between Family History of Type 2 Diabetes Mellitus and Hypertension and Incident Type 2 Diabetes Mellitus and Hypertension
Tidsramme: 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.
Up to 5 years
Time to Development of Type 2 Diabetes Mellitus in Participants With Prediabetes at Baseline
Tidsramme: 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.
Up to 5 years
Time to Development of Hypertension in Participants With Prehypertension at Baseline
Tidsramme: 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.
Up to 5 years
Latent Structures of Social and Environmental Determinants and Their Association With Incident Type 2 Diabetes Mellitus and Hypertension
Tidsramme: 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.
Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Coordinación de Investigación en Salud, Mexico

Samarbeidspartnere

Instituto Mexicano del Seguro Social
Secretaria de Salud, Mexico

Etterforskere

  • Hovedetterforsker: Rodolfo Rivas, PhD, Instituto Mexicano del Seguro Social

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. august 2031

Studiet fullført (Antatt)

1. desember 2031

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R-2026-785-027

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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