iCaReMe グローバル レジストリ (iCaReMe)
2026年9月7日 更新者:AstraZeneca
2型糖尿病、高血圧、心不全および/または慢性腎臓病患者の管理とケアの質を決定するための現実世界の多国籍レジストリ
2 型糖尿病、高血圧、心不全、および/または慢性腎臓病患者の患者特性、疾患管理、医療利用、転帰に関する実世界のデータを提供する
調査の概要
詳細な説明
レジストリは、多くの国の臨床診療における 2 型糖尿病、高血圧、熱中症、および慢性腎臓病患者の患者管理とケアの質に関する実際のデータを提供することを目的としています。
このギャップを埋めるために、2 型糖尿病、高血圧、心不全、および慢性腎臓病患者の患者特性、疾患管理、医療利用、転帰に関する実際のデータを取得するために、任意の観察レジストリが設定されています。
クラウドベースの eCRF を利用した多国籍の観察レジストリで、研究者や科学委員会がアクセスできる前向きおよび遡及的なデータ収集が可能です。
このレジストリは、世界中の 2 型糖尿病、HTN、HF、または CKD を管理しているすべての医師に公開されます。
研究の種類
観察的
入学 (推定)
35000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:AstraZeneca Clinical Study Information Center
- 電話番号:1-877-240-9479
- メール:information.center@astrazeneca.com
研究場所
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Sharjah city、アラブ首長国連邦
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Sulaymaniyah、イラク、46001
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Ahmedabad、インド
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Kolkata、インド、700034
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Mumbai、インド、400006
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Dnipropetrovsk Oblast
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Dnipro、Dnipropetrovsk Oblast、ウクライナ、49005
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Kharkiv Oblast
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Kharkiv、Kharkiv Oblast、ウクライナ、61039
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Kharkiv、Kharkiv Oblast、ウクライナ
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Kyiv Oblast
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Kyiv、Kyiv Oblast、ウクライナ、3039
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Kyiv、Kyiv Oblast、ウクライナ、4050
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Vinnytsia Oblast
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Vinnytsia、Vinnytsia Oblast、ウクライナ、21000
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Volyn Oblast
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Lutsk、Volyn Oblast、ウクライナ、43024
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Zakarpattia Oblast
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Uzhhorod、Zakarpattia Oblast、ウクライナ、88000
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Zaporizhzhia Oblast
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Zaporizhzhya、Zaporizhzhia Oblast、ウクライナ、69035
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Alexandria、エジプト
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Cairo、エジプト
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Giza、エジプト
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Aktobe、カザフスタン、30019
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- Research Site
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Almaty、カザフスタン、50000
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- Research Site
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Almaty、カザフスタン、50006
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Almaty、カザフスタン、50012
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Almaty、カザフスタン、50054
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Kumasi、ガーナ
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Tbilisi、グルジア
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Nairobi、ケニア、14497
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San José、コスタリカ
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Abidjan、コートジボワール
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Santiago Metropolitan
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Providencia、Santiago Metropolitan、チリ、7500922
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Enugu、ナイジェリア、400001
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Gwagwalada、ナイジェリア、901002
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Kano、ナイジェリア、700233
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Bulacan、フィリピン
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Cebu City、フィリピン
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Iloilo City、フィリピン
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Laguna、フィリピン
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Mandaluyong、フィリピン
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Manila、フィリピン
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Mindoro、フィリピン
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Pampanga、フィリピン
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Quezon City、フィリピン
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Zamboanga City、フィリピン
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São Paulo、ブラジル、05403-000
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São Paulo、ブラジル、05403-900
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Ceará
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Fortaleza、Ceará、ブラジル、60840-285
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Espírito Santo (ES)
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Colatina、Espírito Santo (ES)、ブラジル、29707-035
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Estado de Bahia
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Salvador、Estado de Bahia、ブラジル、40730-220
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Federal District
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Brasília、Federal District、ブラジル、70673-623
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Minas Gerais
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Poços de Caldas、Minas Gerais、ブラジル、37706-106
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Paraná
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Campina Grande do Sul、Paraná、ブラジル、83430-000
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Curitiba、Paraná、ブラジル、80230-020
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Piauí (PI)
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Teresina、Piauí (PI)、ブラジル、64001-450
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Rio Grande Do Sul (RS)
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Santa Cruz do Sul、Rio Grande Do Sul (RS)、ブラジル、96835-090
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State of Goias
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Goiânia、State of Goias、ブラジル、74453-200
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State of Santa Catarina
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Joinville、State of Santa Catarina、ブラジル、89204-248
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São Paulo
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Bragança Paulista、São Paulo、ブラジル、12916-542
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São Caetano do Sul、São Paulo、ブラジル、09521-160
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Kuala Lumpur、マレーシア
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Iztapalapa、メキシコ
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Mexico City、メキシコ、06720
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Mexico City、メキシコ
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México、メキシコ、04530
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Guanajuato
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León、Guanajuato、メキシコ、37549
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Florida、南アフリカ、1794
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Parow、南アフリカ、7505
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Umhlanga、南アフリカ、4320
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Umhlanga、南アフリカ、4319
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Changhua、台湾、500209
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Kaohsiung City、台湾、81301
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Niaosong、台湾、83301
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Taichung、台湾、40447
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Taichung、台湾、40705
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Taichung、台湾
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Tainan、台湾、704
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Taipei、台湾
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Taoyuan City、台湾、33305
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Wan Chai、香港
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
2型糖尿病、高血圧、心不全および/または慢性腎臓病の成人
説明
包含基準:
- 18歳以上であること
- 2型糖尿病、高血圧、心不全および/または慢性腎臓病を患っている
- レジストリに参加するための書面によるインフォームド コンセントの提供
除外基準:
- 生命を脅かす併存疾患があり、平均余命が1年未満である
- -インフォームドコンセントを必要とする介入試験への参加
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:他の
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
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T2DM Cohort
Patients with T2DM as enrollment motif or T2DM as comorbidity
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HTN Cohort
Patients with HTN as enrollment motif or HTN as comorbidity
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CKD Cohort
Patients with CKD as enrollment motif or CKD as comorbidity
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HF Cohort
Patients with HF as enrollment motif or HF as comorbidity
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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 |
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1. Age of particpants
時間枠:At Baseline
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Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
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At Baseline
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2. Percentage of Participants by Sex
時間枠:At baseline
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Distribution of participants by sex (male/female) reported as counts and percentages.
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At baseline
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3. Percentage of Participants by Ethnicity
時間枠:At Baseline
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Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
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At Baseline
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4. Percentage of Participants by Education Level
時間枠:At Baseline
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Distribution of participants by education level reported as counts and percentages for each education category.
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At Baseline
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5. Percentage of Participants by Marital Status
時間枠:At Baseline
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Distribution of participants by marital status reported as counts and percentages for each marital status category.
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At Baseline
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6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease
時間枠:At Baseline
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Percentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.
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At Baseline
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7.Percentage of Participants by Physical Activity Level
時間枠:At Baseline
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Distribution of participants by physical activity level category reported as counts and percentages.
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At Baseline
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8. Percentage of Participants by Smoking Status
時間枠:At Baseline
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Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
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At Baseline
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9. Percentage of Participants by Alcohol Consumption
時間枠:At Baseline
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Distribution of participants by alcohol consumption category reported as counts and percentages.
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At Baseline
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10. Body Weight of Participants
時間枠:At Baseline
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Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
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At Baseline
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11. Height of Participants
時間枠:At Baseline
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Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
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At Baseline
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12. Body Mass Index (BMI) of Participants
時間枠:At Baseline
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Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
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At Baseline
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13. Waist Circumference of Participants
時間枠:At Baseline
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Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
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At Baseline
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14. Waist-to-Hip Ratio of Participants
時間枠:At Baseline
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Waist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
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At Baseline
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15. Waist-to-Height Ratio of Participants
時間枠:At Baseline
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Waist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
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At Baseline
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16. Percentage of Participants by Cardiac and Renal Functional Measurements Category
時間枠:At Baseline
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Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
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At Baseline
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17. Primary Disease Duration
時間枠:At Baseline
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Duration of primary disease (T2DM, HTN, HF, or CKD) from initial diagnosis to enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
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At Baseline
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18. Percentage of Participants by Number and Types of Comorbidities
時間枠:At Baseline
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Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
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At Baseline
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19. Percentage of Participants by NYHA Functional Class
時間枠:At Baseline
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Distribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.
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At Baseline
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20. Percentage of Participants by Heart Failure Phenotype
時間枠:At Baseline
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Distribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.
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At Baseline
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21. Percentage of Participants by Heart Failure Etiology
時間枠:At Baseline
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Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
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At Baseline
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22. Percentage of Participants by CKD Etiology
時間枠:At Baseline
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Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
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At Baseline
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23. Percentage of Participants by Hypertension Stage
時間枠:At Baseline
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Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
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At Baseline
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24. Percentage of Participants by Secondary Hypertension Etiology
時間枠:At Baseline
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Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
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At Baseline
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25. Office Systolic and Diastolic Blood Pressure
時間枠:At Baseline
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Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
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At Baseline
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26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values
時間枠:At Baseline
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Home blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
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At Baseline
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27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
時間枠:At Baseline
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Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
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At Baseline
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28. Blood HbA1c
時間枠:Average of 3 years
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HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
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Average of 3 years
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29. Fasting Glucose
時間枠:Average of 3 years
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Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
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Average of 3 years
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30. Lipid Profile Testing
時間枠:Average of 3 years
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Total cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
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Average of 3 years
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31. Serum Creatinine
時間枠:Average of 3 years
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Serum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
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Average of 3 years
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32. Estimated Glomerular Filtration Rate (eGFR)
時間枠:Average of 3 years
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Estimated glomerular filtration rate (eGFR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mL/min/1.73m².
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Average of 3 years
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33. Urine Albumin-to-Creatinine Ratio (UACR)
時間枠:Average of 3 years
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Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
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Average of 3 years
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34. Serum Electrolyte Values
時間枠:Avergae of 3 years
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Serum electrolyte values (sodium, potassium, chloride, bicarbonate) reported individually as mean ± standard deviation (SD) and median with interquartile range (IQR) in mmol/L.
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Avergae of 3 years
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35. Frequency of HbA1c Testing
時間枠:Average of 3 years
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Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
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Average of 3 years
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36. Frequency of Fasting Glucose Testing
時間枠:Average of 3 years
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Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
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Average of 3 years
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37. Frequency of Lipid Profile Testing
時間枠:Average of 3 years
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Frequency of lipid profile testing (total cholesterol, LDL-C, HDL-C, triglycerides) reported as counts and percentages of participants tested per monitoring period.
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Average of 3 years
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38. Frequency of Serum Creatinine Testing
時間枠:Average of 3 years
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Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
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Average of 3 years
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39. Frequency of eGFR Assessment
時間枠:Average of 3 years
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Frequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.
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Average of 3 years
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40. Frequency of Urine Albumin-to-Creatinine Ratio Testing
時間枠:Average of 3 years
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Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
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Average of 3 years
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41. Echocardiography
時間枠:Average of 3 years
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Frequency of echocardiography abnormalities reported as counts and percentages
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Average of 3 years
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42. Electrocardiogram (ECG)
時間枠:Average of 3 years
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Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
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Average of 3 years
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43. Participants Receiving Dietary Modification Counseling
時間枠:Average of 3 years
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Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
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Average of 3 years
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44. Participants Enrolled in Exercise Programs
時間枠:Average of 3 years
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Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
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Average of 3 years
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45. Participants Receiving Weight Management Interventions
時間枠:Average of 3 years
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Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
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Average of 3 years
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46. Participants Receiving Smoking Cessation Counseling
時間枠:Average of 3 years
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Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
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Average of 3 years
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47. Participants Receiving Alcohol Reduction Counseling
時間枠:Average of 3 years
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Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
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Average of 3 years
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48. Percentage of Participants by Line of Treatment
時間枠:Average of 3 years
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Distribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.
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Average of 3 years
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49. Percentage of Participants by Drug Class
時間枠:Average of 3 years
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Distribution of participants by drug class prescribed (e.g., SGLT2i, GLP-1RA, ACEi, ARBs, beta-blockers, MRAs, CCBs, diuretics, metformin, DPP-4i, sulfonylureas, insulin) reported as counts and percentages.
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Average of 3 years
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50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)
時間枠:Average of 3 years
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Percentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.
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Average of 3 years
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51. Percentage of Participants Receiving Dialysis
時間枠:Average of 3 years
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Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
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Average of 3 years
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52. Percentage of Participants with Cardiac Device Implantation
時間枠:Average of 3 years
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Percentage of participants with cardiac device implantation (pacemaker, implantable cardioverter-defibrillator [ICD], or cardiac resynchronization therapy [CRT]) reported as counts and percentages for each device type.
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Average of 3 years
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53. Mean Duration of Pharmacological Treatments
時間枠:Average of 3 years
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Duration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.
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Average of 3 years
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54. Drug Dose of Pharmacological Treatments
時間枠:Average of 3 years
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Drug dose of pharmacological treatments prescribed reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in milligrams (mg) for each drug class.
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Average of 3 years
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55. Number of Primary Care Visits per Participant
時間枠:Average of 3 years
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Total number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).
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Average of 3 years
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56. Number of Tertiary Care Hospital Visits per Participant
時間枠:Average of 3 years
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Total number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).
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Average of 3 years
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57. Number of Specialist Care Visits per Participant
時間枠:Average of 3 years
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Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
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Average of 3 years
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58.Number of Emergency Department Visits per Participant
時間枠:Average of 3 years
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Total number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
59. All-Cause Hospitalizations
時間枠:Average of 3 years
|
All-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
|
Average of 3 years
|
|
60. Disease-Specific Hospitalizations
時間枠:Average of 3 years
|
Disease-specific hospitalizations (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
|
Average of 3 years
|
|
61. All-Cause Emergency Department Visits
時間枠:Average of 3 years
|
All-cause emergency department visits reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
|
Average of 3 years
|
|
62. Disease-Specific Emergency Department Visits
時間枠:Average of 3 years
|
Disease-specific emergency department visits (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
|
Average of 3 years
|
|
63. Length of Hospital Stay
時間枠:Average of 3 years
|
Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.
|
Average of 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
時間枠:Average of 3 years
|
Hypoglycemic events defined as blood glucose <70 mg/dL (Level 1 - alert value) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
|
Average of 3 years
|
|
2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL)
時間枠:Average of 3 years
|
Hypoglycemic events defined as blood glucose <54 mg/dL (Level 2 - clinically significant) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
|
Average of 3 years
|
|
3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance)
時間枠:Average of 3 years
|
Severe hypoglycemic events requiring third-party assistance (Level 3) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
|
Average of 3 years
|
|
4.Incidence of Diabetic Ketoacidosis (DKA) Episodes
時間枠:Average of 3 years
|
Diabetic ketoacidosis (DKA) episodes reported as counts, percentages of participants with at least one episode, and total number of episodes.
|
Average of 3 years
|
|
5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%)
時間枠:Average of 3 years
|
Percentage of participants with uncontrolled type 2 diabetes mellitus defined as HbA1c ≥7% reported as counts and percentages.
|
Average of 3 years
|
|
6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg)
時間枠:Average of 3 years
|
Percentage of participants with uncontrolled hypertension defined as blood pressure ≥140/90 mmHg or ≥130/80 mmHg (per applicable guideline threshold) reported as counts and percentages.
|
Average of 3 years
|
|
7. Incidence of Retinopathy
時間枠:Average of 3 years
|
Incidence of retinopathy reported as counts, percentages of participants with new-onset retinopathy, and incidence per 100 person-years.
|
Average of 3 years
|
|
8. Incidence of Nephropathy
時間枠:Average of 3 years
|
Incidence of nephropathy reported as counts, percentages of participants with new-onset nephropathy, and incidence per 100 person-years.
|
Average of 3 years
|
|
9. Incidence of Neuropathy
時間枠:Average of 3 years
|
Incidence of neuropathy reported as counts, percentages of participants with new-onset neuropathy, and incidence per 100 person-years.
|
Average of 3 years
|
|
10. Incidence of Myocardial Infarction (MI)
時間枠:Average of 3 years
|
Incidence of myocardial infarction (MI) reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
|
Average of 3 years
|
|
11. Incidence of Stroke
時間枠:Average of 3 years
|
Incidence of stroke reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
|
Average of 3 years
|
|
12. Incidence of Peripheral Arterial Disease (PAD)
時間枠:Average of 3 years
|
Incidence of peripheral arterial disease (PAD) reported as counts, percentages of participants with new-onset PAD, and incidence per 100 person-years.
|
Average of 3 years
|
|
13. Incidence of Coronary Revascularization
時間枠:Average of 3 years
|
Incidence of coronary revascularization procedures reported as counts, percentages of participants undergoing revascularization, and incidence per 100 person-years.
|
Average of 3 years
|
|
14. Incidence of New-Onset Heart Failure
時間枠:Average of 3 years
|
Incidence of new-onset heart failure diagnosis reported as counts, percentages of participants with new HF diagnosis, and incidence per 100 person-years.
|
Average of 3 years
|
|
15. Incidence of New-Onset Chronic Kidney Disease
時間枠:Average of 3 years
|
Incidence of new-onset chronic kidney disease defined as eGFR <60 mL/min/1.73m²
or urine albumin-to-creatinine ratio (UACR) ≥30 mg/g reported as counts, percentages of participants, and incidence per 100 person-years.
|
Average of 3 years
|
|
16. Percentage of Participants Developing Anemia
時間枠:Average of 3 years
|
Percentage of participants developing anemia as a cardio-renal complication reported as counts and percentages.
|
Average of 3 years
|
|
17. Percentage of Participants Developing Hyperkalemia
時間枠:Average of 3 years
|
Percentage of participants developing hyperkalemia as a cardio-renal complication reported as counts and percentages.
|
Average of 3 years
|
|
18. Percentage of Participants with Heart Failure Hospitalization
時間枠:Average of 3 years
|
Percentage of participants with at least one heart failure hospitalization reported as counts and percentages.
|
Average of 3 years
|
|
19. Percentage of Participants with eGFR Decline
時間枠:Average of 3 years
|
Percentage of participants experiencing a clinically significant decline in estimated glomerular filtration rate (eGFR) reported as counts and percentages.
|
Average of 3 years
|
|
20. Percentage of Participants with RRT Initiation or ESRD Progression
時間枠:Average of 3 years
|
Percentage of participants initiating renal replacement therapy (RRT) or progressing to end-stage renal disease (ESRD) reported as counts and percentages.
|
Average of 3 years
|
|
21. Incidence of Renal Replacement Therapy Initiation or ESRD Progression
時間枠:Average of 3 years
|
Incidence of renal replacement therapy (RRT) initiation or progression to end-stage renal disease (ESRD) reported as counts, percentages of participants, and rate per 100 person-years.
|
Average of 3 years
|
|
22. Incidence of All-Cause Mortality
時間枠:Average of 3 years
|
All-cause mortality reported as counts, percentages of participants, and rate per 100 person-years.
|
Average of 3 years
|
|
23. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Incidence of Hypoglycemic Events
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and incidence of hypoglycemic events.
|
Average of 3 years
|
|
24. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled T2DM
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled T2DM (HbA1c ≥7%).
|
Average of 3 years
|
|
26. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled HTN
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled HTN (BP ≥140/90 mmHg).
|
Average of 3 years
|
|
27. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Heart Failure Worsening
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and heart failure worsening.
|
Average of 3 years
|
|
28. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and CKD Progression/RRT Initiation/ESRD Progression
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and CKD Progression/RRT Initiation/ESRD Progression
|
Average of 3 years
|
|
29. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and All-cause mortality
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and All-cause mortality
|
Average of 3 years
|
|
30. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and and Myocardial Infarction/Stroke/PAD
時間枠:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and Myocardial Infarction/Stroke/PAD
|
Average of 3 years
|
|
31. Correlation Between Patient Characteristics and Treatment Choices for T2DM
時間枠:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for T2DM (line of treatment and drug class: metformin, SGLT2i, GLP-1RA, DPP-4i, sulfonylureas, insulin).
|
Average of 3 years
|
|
32. Correlation Between Patient Characteristics and Treatment Choices for HTN
時間枠:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HTN (line of treatment and drug class: ACEi, ARBs, CCBs, beta-blockers, diuretics).
|
Average of 3 years
|
|
33. Correlation Between Patient Characteristics and Treatment Choices for HF
時間枠:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HF (line of treatment and drug class: ACEi, ARBs, ARNI, beta-blockers, MRAs, SGLT2i).
|
Average of 3 years
|
|
34. Correlation Between Patient Characteristics and Treatment Choices for CKD
時間枠:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for CKD (line of treatment and drug class: ACEi, ARBs, SGLT2i).
|
Average of 3 years
|
|
35. Percentage of Participants with Dyslipidemia by Category
時間枠:Average of 3 years
|
Distribution of participants with dyslipidemia by category reported as counts and percentages.
|
Average of 3 years
|
|
36. Percentage of Participants with Obesity by Category
時間枠:Average of 3 years
|
Distribution of participants with obesity by BMI category reported as counts and percentages.
|
Average of 3 years
|
|
37. Percentage of Participants Achieving LDL-C Target <100 mg/dL
時間枠:Average of 3 years
|
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <100 mg/dL reported as counts and percentages.
|
Average of 3 years
|
|
38. Percentage of Participants Achieving LDL-C Target <70 mg/dL
時間枠:Average of 3 years
|
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <70 mg/dL reported as counts and percentages.
|
Average of 3 years
|
|
40. Percentage of Participants Achieving Weight Loss ≥5%
時間枠:Average of 3 years
|
Percentage of participants achieving weight loss of 5% or more from baseline reported as counts and percentages.
|
Average of 3 years
|
|
41. Percentage of Participants Achieving Weight Loss ≥10%
時間枠:Average of 3 years
|
Percentage of participants achieving weight loss of 10% or more from baseline reported as counts and percentages.
|
Average of 3 years
|
|
42. Percentage of Participants Achieving Weight Loss ≥15%
時間枠:Average of 3 years
|
Percentage of participants achieving weight loss of 15% or more from baseline reported as counts and percentages.
|
Average of 3 years
|
|
43. Percentage of Participants Developing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
時間枠:Average of 3 years
|
Percentage of participants developing metabolic dysfunction-associated steatotic liver disease (MASLD) as an obesity complication reported as counts and percentages.
|
Average of 3 years
|
|
44. Percentage of Participants Developing T2DM as an Obesity Complication
時間枠:Average of 3 years
|
Percentage of participants developing new-onset type 2 diabetes mellitus (T2DM) as an obesity complication reported as counts and percentages.
|
Average of 3 years
|
|
45. Incidence of Myocardial Infarction/Stroke in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Incidence of myocardial infarction (MI)/stroke in participants with dyslipidemia and/or obesity reported as counts and percentages.
|
Average of 3 years
|
|
46. Lipid levels in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Total cholesterol, LDL-C, HDL-C, Triglyceride in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
|
Average of 3 years
|
|
47. Body Weight in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Body weight in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
|
Average of 3 years
|
|
48. BMI in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Body mass index (BMI) in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
|
Average of 3 years
|
|
49. Waist Circumference in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Waist circumference in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
|
Average of 3 years
|
|
50. Waist-to-Hip Ratio in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years through
|
Waist-to-hip ratio in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
|
Average of 3 years through
|
|
51. Frequency of Lipid Profile Monitoring in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Frequency of lipid profile testing in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
|
Average of 3 years
|
|
52. Frequency of Weight and BMI Monitoring in Participants with Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Frequency of weight and BMI measurements in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
|
Average of 3 years
|
|
53. Frequency of Obesity Complication Assessments
時間枠:Average of 3 years
|
Frequency of obesity complication assessments (screening for MASLD, T2DM, cardiovascular risk) reported as counts and percentages of participants assessed per clinical guidelines.
|
Average of 3 years
|
|
54. Percentage of Participants Receiving Lifestyle Modifications for Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Percentage of participants receiving lifestyle modification interventions (dietary, exercise, behavioral) for dyslipidemia and/or obesity management reported as counts and percentages.
|
Average of 3 years
|
|
55. Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
時間枠:Average of 3 years
|
Counts and Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
|
Average of 3 years
|
|
56. Percentage of Participants Undergoing Bariatric Surgery
時間枠:Average of 3 years
|
Percentage of participants undergoing bariatric surgery for obesity management reported as counts and percentages.
|
Average of 3 years
|
|
57. Mean Number of Visits for Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Number of visits for dyslipidemia and/or obesity management reported as counts and percentages of participants with at least one visit.
Visits for dyslipidemia and/or obesity management reported as mean ± standard deviation (SD) and total visits.
|
Average of 3 years
|
|
58. Percentage of Participants Hospitalized for Dyslipidemia/Obesity
時間枠:Average of 3 years
|
Percentage of participants with at least one hospitalization related to dyslipidemia and/or obesity reported as counts and percentages.
Hospitalizations for dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and total hospitalizations.
|
Average of 3 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター:Hardik Vasnawala, MD、AstraZeneca
- スタディディレクター:Isidro Villanueva, MD、AstraZeneca
- スタディディレクター:Ahmed Hadaoui, PharmD、AstraZeneca
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年2月17日
一次修了 (推定)
2030年12月31日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2018年5月15日
QC基準を満たした最初の提出物
2018年5月29日
最初の投稿 (実際)
2018年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年8月1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
- D1690R00044
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?
はい
IPD プランの説明
資格のある研究者は、リクエスト ポータルを介して、アストラゼネカが臨床試験を後援する企業グループから匿名化された個々の患者レベルのデータへのアクセスをリクエストできます。 すべてのリクエストは、AZ 開示コミットメントに従って評価されます。
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. はい、AZ が IPD の要求を受け入れていることを示しますが、これはすべての要求が共有されるという意味ではありません。
IPD 共有時間枠
アストラゼネカは、EFPIA Pharma Data Sharing Principles へのコミットメントに従って、データの可用性を満たしているか、それを上回っています。
タイムラインの詳細については、https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure の開示に関するコミットメントを参照してください。
IPD 共有アクセス基準
要求が承認されると、アストラゼネカは、承認済みのスポンサー付きツールで匿名化された個々の患者レベルのデータへのアクセスを提供します。
要求された情報にアクセスする前に、署名済みのデータ共有契約 (データ アクセサーのための交渉不可の契約) を締結する必要があります。
さらに、すべてのユーザーがアクセスするには、SAS MSE の利用規約に同意する必要があります。
詳細については、https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure で開示声明を確認してください。
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
いいえ
米国FDA規制機器製品の研究
いいえ
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