iCaReMe 글로벌 레지스트리 (iCaReMe)
2026년 9월 7일 업데이트: AstraZeneca
제2형 당뇨병, 고혈압, 심부전 및/또는 만성 신장 질환 환자의 관리 및 치료 품질을 결정하기 위한 실제 다국적 레지스트리
제2형 당뇨병, 고혈압, 심부전 및/또는 만성 신장 질환 환자의 환자 특성, 질병 관리, 의료 이용 및 결과에 대한 실제 데이터를 제공합니다.
연구 개요
상태
상태
모병
상세 설명
레지스트리는 많은 국가의 임상 실습에서 T2DM, 고혈압, 열부전 및 만성 신장 질환 환자에 대한 환자 관리 및 치료 품질에 대한 실제 데이터를 제공할 계획입니다.
이 격차를 해소하기 위해 제2형 당뇨병, 고혈압, 심부전 및 만성 신장 질환 환자의 환자 특성, 질병 관리, 의료 이용 및 결과에 대한 실제 데이터를 수집하기 위해 관찰 자발적 등록이 설정되었습니다.
클라우드 기반 eCRF를 활용하는 다국적 관측 레지스트리로, 조사관과 과학 위원회가 액세스할 수 있는 전향적 및 후향적 데이터 수집용입니다.
이 레지스트리는 전 세계에서 T2DM, HTN, HF 또는 CKD를 관리하는 모든 의사에게 공개됩니다.
연구 유형
연구 유형
관찰
등록 (추정된)
등록
35000
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
연구 장소
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Kumasi, 가나
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Tbilisi, 그루지야
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Enugu, 나이지리아, 400001
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Gwagwalada, 나이지리아, 901002
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Kano, 나이지리아, 700233
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Florida, 남아프리카, 1794
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Parow, 남아프리카, 7505
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Umhlanga, 남아프리카, 4320
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Umhlanga, 남아프리카, 4319
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Changhua, 대만, 500209
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Kaohsiung City, 대만, 81301
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Niaosong, 대만, 83301
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Taichung, 대만, 40447
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Taichung, 대만, 40705
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Taichung, 대만
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Tainan, 대만, 704
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Taipei, 대만
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Taoyuan City, 대만, 33305
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Kuala Lumpur, 말레이시아
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Iztapalapa, 멕시코
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Mexico City, 멕시코, 06720
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Mexico City, 멕시코
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México, 멕시코, 04530
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Guanajuato
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León, Guanajuato, 멕시코, 37549
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São Paulo, 브라질, 05403-000
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São Paulo, 브라질, 05403-900
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Ceará
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Fortaleza, Ceará, 브라질, 60840-285
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Espírito Santo (ES)
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Colatina, Espírito Santo (ES), 브라질, 29707-035
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Estado de Bahia
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Salvador, Estado de Bahia, 브라질, 40730-220
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Federal District
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Brasília, Federal District, 브라질, 70673-623
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Minas Gerais
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Poços de Caldas, Minas Gerais, 브라질, 37706-106
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Paraná
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Campina Grande do Sul, Paraná, 브라질, 83430-000
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Curitiba, Paraná, 브라질, 80230-020
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Piauí (PI)
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Teresina, Piauí (PI), 브라질, 64001-450
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Rio Grande Do Sul (RS)
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Santa Cruz do Sul, Rio Grande Do Sul (RS), 브라질, 96835-090
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State of Goias
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Goiânia, State of Goias, 브라질, 74453-200
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State of Santa Catarina
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Joinville, State of Santa Catarina, 브라질, 89204-248
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São Paulo
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Bragança Paulista, São Paulo, 브라질, 12916-542
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São Caetano do Sul, São Paulo, 브라질, 09521-160
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Sharjah city, 아랍 에미리트
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Dnipropetrovsk Oblast
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Dnipro, Dnipropetrovsk Oblast, 우크라이나, 49005
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Kharkiv Oblast
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Kharkiv, Kharkiv Oblast, 우크라이나, 61039
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Kharkiv, Kharkiv Oblast, 우크라이나
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Kyiv Oblast
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Kyiv, Kyiv Oblast, 우크라이나, 3039
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Kyiv, Kyiv Oblast, 우크라이나, 4050
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Vinnytsia Oblast
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Vinnytsia, Vinnytsia Oblast, 우크라이나, 21000
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Volyn Oblast
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Lutsk, Volyn Oblast, 우크라이나, 43024
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Zakarpattia Oblast
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Uzhhorod, Zakarpattia Oblast, 우크라이나, 88000
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Zaporizhzhia Oblast
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Zaporizhzhya, Zaporizhzhia Oblast, 우크라이나, 69035
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Sulaymaniyah, 이라크, 46001
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Alexandria, 이집트
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Cairo, 이집트
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Giza, 이집트
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Ahmedabad, 인도
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Kolkata, 인도, 700034
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Mumbai, 인도, 400006
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Santiago Metropolitan
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Providencia, Santiago Metropolitan, 칠레, 7500922
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Aktobe, 카자흐스탄, 30019
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Almaty, 카자흐스탄, 50000
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Almaty, 카자흐스탄, 50006
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Almaty, 카자흐스탄, 50012
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Almaty, 카자흐스탄, 50054
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Nairobi, 케냐, 14497
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San José, 코스타리카
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Abidjan, 코트 디부 아르
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Bulacan, 필리핀 제도
- 아직 모집하지 않음
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Cebu City, 필리핀 제도
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Iloilo City, 필리핀 제도
- 아직 모집하지 않음
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Laguna, 필리핀 제도
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Mandaluyong, 필리핀 제도
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Manila, 필리핀 제도
- 아직 모집하지 않음
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Mindoro, 필리핀 제도
- 아직 모집하지 않음
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Pampanga, 필리핀 제도
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Quezon City, 필리핀 제도
- 아직 모집하지 않음
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Zamboanga City, 필리핀 제도
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Wan Chai, 홍콩
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
제2형 당뇨병, 고혈압, 심부전 및/또는 만성 신장 질환이 있는 성인
설명
포함 기준:
- 만 18세 이상
- 제2형 당뇨병, 고혈압, 심부전 및/또는 만성 신장 질환이 있는 경우
- 레지스트리 참여에 대한 서면 동의 제공
제외 기준:
- 기대 수명이 1년 미만인 생명을 위협하는 동반 질환이 있는 경우
- 정보에 입각한 동의가 필요한 중재적 임상시험 참여
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
그룹/코호트 수
4
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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1. Age of particpants
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At Baseline
|
Distribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.
|
At Baseline
|
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20. Percentage of Participants by Heart Failure Phenotype
기간: At Baseline
|
Distribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.
|
At Baseline
|
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21. Percentage of Participants by Heart Failure Etiology
기간: At Baseline
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Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
|
At Baseline
|
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22. Percentage of Participants by CKD Etiology
기간: At Baseline
|
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
기간: 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
기간: 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
기간: At Baseline
|
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
기간: At Baseline
|
Home blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
|
At Baseline
|
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27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
기간: At Baseline
|
Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
|
At Baseline
|
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28. Blood HbA1c
기간: Average of 3 years
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HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
|
Average of 3 years
|
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29. Fasting Glucose
기간: 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
|
Average of 3 years
|
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30. Lipid Profile Testing
기간: Average of 3 years
|
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
기간: Average of 3 years
|
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)
기간: Average of 3 years
|
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)
기간: 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
기간: Avergae of 3 years
|
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
기간: Average of 3 years
|
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
기간: Average of 3 years
|
Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
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37. Frequency of Lipid Profile Testing
기간: Average of 3 years
|
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
기간: Average of 3 years
|
Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
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39. Frequency of eGFR Assessment
기간: Average of 3 years
|
Frequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.
|
Average of 3 years
|
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40. Frequency of Urine Albumin-to-Creatinine Ratio Testing
기간: Average of 3 years
|
Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
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41. Echocardiography
기간: Average of 3 years
|
Frequency of echocardiography abnormalities reported as counts and percentages
|
Average of 3 years
|
|
42. Electrocardiogram (ECG)
기간: Average of 3 years
|
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
|
Average of 3 years
|
|
43. Participants Receiving Dietary Modification Counseling
기간: Average of 3 years
|
Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
|
Average of 3 years
|
|
44. Participants Enrolled in Exercise Programs
기간: Average of 3 years
|
Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
|
Average of 3 years
|
|
45. Participants Receiving Weight Management Interventions
기간: Average of 3 years
|
Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
|
Average of 3 years
|
|
46. Participants Receiving Smoking Cessation Counseling
기간: Average of 3 years
|
Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
|
Average of 3 years
|
|
47. Participants Receiving Alcohol Reduction Counseling
기간: Average of 3 years
|
Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
|
Average of 3 years
|
|
48. Percentage of Participants by Line of Treatment
기간: Average of 3 years
|
Distribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.
|
Average of 3 years
|
|
49. Percentage of Participants by Drug Class
기간: Average of 3 years
|
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.
|
Average of 3 years
|
|
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)
기간: Average of 3 years
|
Percentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.
|
Average of 3 years
|
|
51. Percentage of Participants Receiving Dialysis
기간: Average of 3 years
|
Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
|
Average of 3 years
|
|
52. Percentage of Participants with Cardiac Device Implantation
기간: Average of 3 years
|
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.
|
Average of 3 years
|
|
53. Mean Duration of Pharmacological Treatments
기간: Average of 3 years
|
Duration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.
|
Average of 3 years
|
|
54. Drug Dose of Pharmacological Treatments
기간: Average of 3 years
|
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.
|
Average of 3 years
|
|
55. Number of Primary Care Visits per Participant
기간: Average of 3 years
|
Total number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
56. Number of Tertiary Care Hospital Visits per Participant
기간: Average of 3 years
|
Total number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
57. Number of Specialist Care Visits per Participant
기간: Average of 3 years
|
Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
58.Number of Emergency Department Visits per Participant
기간: Average of 3 years
|
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
기간: 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)
기간: 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)
기간: 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
기간: 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%)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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%
기간: 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%
기간: 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%
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Hardik Vasnawala, MD, AstraZeneca
- 연구 책임자: Isidro Villanueva, MD, AstraZeneca
- 연구 책임자: Ahmed Hadaoui, PharmD, AstraZeneca
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2018년 2월 17일
기본 완료 (추정된)
기본 완료
2030년 12월 31일
연구 완료 (추정된)
연구 완료
2030년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2018년 5월 15일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2018년 5월 29일
처음 게시됨 (실제)
처음 게시됨
2018년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- D1690R00044
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
자격을 갖춘 연구원은 요청 포털을 통해 임상 시험을 후원하는 AstraZeneca 그룹의 익명화된 개별 환자 수준 데이터에 대한 액세스를 요청할 수 있습니다. 모든 요청은 AZ 공개 약정에 따라 평가됩니다.
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. 예, AZ가 IPD에 대한 요청을 수락하고 있음을 나타내지만 모든 요청이 공유된다는 의미는 아닙니다.
IPD 공유 기간
AstraZeneca는 EFPIA 제약 데이터 공유 원칙에 대한 약속에 따라 데이터 가용성을 충족하거나 초과할 것입니다.
타임라인에 대한 자세한 내용은 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure에서 공개 약속을 참조하십시오.
IPD 공유 액세스 기준
요청이 승인되면 AstraZeneca는 승인된 후원 도구에서 비식별화된 개별 환자 수준 데이터에 대한 액세스를 제공합니다.
요청된 정보에 액세스하기 전에 서명된 데이터 공유 계약(데이터 접근자를 위한 협상 불가능한 계약)이 있어야 합니다.
또한 모든 사용자가 액세스 권한을 얻으려면 SAS MSE의 약관에 동의해야 합니다.
자세한 내용은 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure에서 공개 성명서를 검토하십시오.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .