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Cohort Study of Metabolic Disease and Hypertension

5. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

2500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Mexiko
    • Mexico City
      • Mexico City, Mexico City, Mexiko, 06720
        • Instituto Mexicano del Seguro Social
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Type 2 Diabetes Mellitus
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Coordinación de Investigación en Salud, Mexico

Mitarbeiter

Instituto Mexicano del Seguro Social
Secretaria de Salud, Mexico

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. August 2031

Studienabschluss (Geschätzt)

1. Dezember 2031

Studienanmeldedaten

Zuerst eingereicht

28. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

11. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R-2026-785-027

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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