Cohort Study of Metabolic Disease and Hypertension
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Rodolfo Rivas Ruiz, PhD
- 電話番号：21264 +52 5556276900
- メール：rodolfo.rivasr@imss.gob.mx
研究場所
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Mexico City
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Mexico City、Mexico City、メキシコ、06720
- Instituto Mexicano del Seguro Social
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コンタクト：
- Rodolfo Rivas Ruiz, PhD
- 電話番号：21264 5556276900
- メール：rodolfo.rivasr@imss.gob.mx
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コンタクト：
- Ivonne Roy García, PhD
- 電話番号：21264 5556276900
- メール：ivonne3316@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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Participants are observed over time without receiving any experimental intervention.
Data are collected as part of routine clinical assessments and scheduled follow-up visits.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Type 2 Diabetes Mellitus
時間枠：Up to 5 years
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New cases of type 2 diabetes mellitus identified during follow-up based on clinical diagnosis, laboratory criteria (fasting glucose or HbA1c), or medical records.
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Up to 5 years
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Incidence of Hypertension
時間枠：Up to 5 years
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New cases of hypertension identified during follow-up based on blood pressure measurements, clinical diagnosis, or medical records.
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Up to 5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Association Between Diet Quality and Incident Type 2 Diabetes Mellitus and Hypertension
時間枠：Up to 5 years
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Assessment of dietary quality and its association with the development of metabolic outcomes during follow-up.
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Up to 5 years
|
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Association Between Changes in Body Weight, Body Composition, and Dyslipidemia With Incident Type 2 Diabetes Mellitus and Hypertension
時間枠：Up to 5 years
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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.
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Up to 5 years
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Association Between Physical Activity Level and Sedentary Behavior With Incident Type 2 Diabetes Mellitus and Hypertension
時間枠：Up to 5 years
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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.
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Up to 5 years
|
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Association Between Physical Fitness Measured by the Six-Minute Walk Test and Incident Type 2 Diabetes Mellitus and Hypertension
時間枠：Up to 5 years
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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.
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Up to 5 years
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Association Between Family History of Type 2 Diabetes Mellitus and Hypertension and Incident Type 2 Diabetes Mellitus and Hypertension
時間枠：Up to 5 years
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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.
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Up to 5 years
|
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Time to Development of Type 2 Diabetes Mellitus in Participants With Prediabetes at Baseline
時間枠：Up to 5 years
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Time from baseline to diagnosis of type 2 diabetes mellitus among participants with prediabetes, based on standard clinical criteria during the follow-up period.
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Up to 5 years
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Time to Development of Hypertension in Participants With Prehypertension at Baseline
時間枠：Up to 5 years
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Time from baseline to diagnosis of hypertension among participants with prehypertension, based on standard clinical criteria during the follow-up period.
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Up to 5 years
|
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Latent Structures of Social and Environmental Determinants and Their Association With Incident Type 2 Diabetes Mellitus and Hypertension
時間枠：Up to 5 years
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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.
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Up to 5 years
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協力者と研究者
捜査官
- 主任研究者：Rodolfo Rivas, PhD、Instituto Mexicano del Seguro Social
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R-2026-785-027
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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