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Globalny rejestr iCaReMe (iCaReMe)

7 września 2026 zaktualizowane przez: AstraZeneca

Prawdziwy wielonarodowy rejestr służący do określania postępowania i jakości opieki nad pacjentami z cukrzycą typu 2, nadciśnieniem tętniczym, niewydolnością serca i/lub przewlekłymi chorobami nerek

Dostarczanie rzeczywistych danych na temat charakterystyki pacjentów, leczenia chorób, wykorzystania opieki zdrowotnej i wyników u pacjentów z cukrzycą typu 2, nadciśnieniem, niewydolnością serca i/lub przewlekłymi chorobami nerek

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

Celem rejestru jest dostarczanie rzeczywistych danych na temat postępowania z pacjentami i jakości opieki nad pacjentami z cukrzycą typu 2, nadciśnieniem tętniczym, niewydolnością cieplną i przewlekłą chorobą nerek w praktyce klinicznej w wielu krajach. Aby wypełnić tę lukę, tworzony jest dobrowolny rejestr obserwacyjny w celu rejestrowania rzeczywistych danych dotyczących charakterystyki pacjentów, leczenia choroby, wykorzystania opieki zdrowotnej i wyników u pacjentów z cukrzycą typu 2, nadciśnieniem, niewydolnością serca i przewlekłą chorobą nerek. Wielonarodowy rejestr obserwacyjny wykorzystujący chmurowy eCRF do prospektywnego i retrospektywnego gromadzenia danych, dostępny dla badaczy i Komitetu Naukowego. Ten rejestr będzie otwarty dla wszystkich lekarzy leczących T2DM, HTN, HF lub CKD na całym świecie.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

35000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Afryka Południowa
      • Florida, Afryka Południowa, 1794
        • Rekrutacyjny
        • Research Site
      • Parow, Afryka Południowa, 7505
        • Rekrutacyjny
        • Research Site
      • Umhlanga, Afryka Południowa, 4320
        • Rekrutacyjny
        • Research Site
      • Umhlanga, Afryka Południowa, 4319
        • Rekrutacyjny
        • Research Site
  • Brazylia
      • São Paulo, Brazylia, 05403-000
        • Rekrutacyjny
        • Research Site
      • São Paulo, Brazylia, 05403-900
        • Rekrutacyjny
        • Research Site
    • Ceará
      • Fortaleza, Ceará, Brazylia, 60840-285
        • Rekrutacyjny
        • Research Site
    • Espírito Santo (ES)
      • Colatina, Espírito Santo (ES), Brazylia, 29707-035
        • Rekrutacyjny
        • Research Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazylia, 40730-220
        • Rekrutacyjny
        • Research Site
    • Federal District
      • Brasília, Federal District, Brazylia, 70673-623
        • Rekrutacyjny
        • Research Site
    • Minas Gerais
      • Poços de Caldas, Minas Gerais, Brazylia, 37706-106
        • Rekrutacyjny
        • Research Site
    • Paraná
      • Campina Grande do Sul, Paraná, Brazylia, 83430-000
        • Rekrutacyjny
        • Research Site
      • Curitiba, Paraná, Brazylia, 80230-020
        • Rekrutacyjny
        • Research Site
    • Piauí (PI)
      • Teresina, Piauí (PI), Brazylia, 64001-450
        • Rekrutacyjny
        • Research Site
    • Rio Grande Do Sul (RS)
      • Santa Cruz do Sul, Rio Grande Do Sul (RS), Brazylia, 96835-090
        • Rekrutacyjny
        • Research Site
    • State of Goias
      • Goiânia, State of Goias, Brazylia, 74453-200
        • Rekrutacyjny
        • Research Site
    • State of Santa Catarina
      • Joinville, State of Santa Catarina, Brazylia, 89204-248
        • Rekrutacyjny
        • Research Site
    • São Paulo
      • Bragança Paulista, São Paulo, Brazylia, 12916-542
        • Rekrutacyjny
        • Research Site
      • São Caetano do Sul, São Paulo, Brazylia, 09521-160
        • Rekrutacyjny
        • Research Site
  • Chile
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500922
        • Rekrutacyjny
        • Research Site
  • Côte d’Ovoire
      • Abidjan, Côte d’Ovoire
        • Rekrutacyjny
        • Research Site
  • Egipt
      • Alexandria, Egipt
        • Rekrutacyjny
        • Research Site
      • Cairo, Egipt
        • Rekrutacyjny
        • Research Site
      • Giza, Egipt
        • Rekrutacyjny
        • Research Site
  • Filipiny
      • Bulacan, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Cebu City, Filipiny
        • Rekrutacyjny
        • Research Site
      • Iloilo City, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Laguna, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Mandaluyong, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Manila, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Mindoro, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Pampanga, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Quezon City, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
      • Zamboanga City, Filipiny
        • Jeszcze nie rekrutacja
        • Research Site
  • Ghana
      • Kumasi, Ghana
        • Rekrutacyjny
        • Research Site
  • Gruzja
      • Tbilisi, Gruzja
        • Rekrutacyjny
        • Research Site
  • Hongkong
      • Wan Chai, Hongkong
        • Rekrutacyjny
        • Research Site
  • Indie
      • Ahmedabad, Indie
        • Rekrutacyjny
        • Research Site
      • Kolkata, Indie, 700034
        • Rekrutacyjny
        • Research Site
      • Mumbai, Indie, 400006
        • Rekrutacyjny
        • Research Site
  • Irak
      • Sulaymaniyah, Irak, 46001
        • Rekrutacyjny
        • Research Site
  • Kazachstan
      • Aktobe, Kazachstan, 30019
        • Rekrutacyjny
        • Research Site
      • Almaty, Kazachstan, 50000
        • Rekrutacyjny
        • Research Site
      • Almaty, Kazachstan, 50006
        • Rekrutacyjny
        • Research Site
      • Almaty, Kazachstan, 50012
        • Rekrutacyjny
        • Research Site
      • Almaty, Kazachstan, 50054
        • Rekrutacyjny
        • Research Site
  • Kenia
      • Nairobi, Kenia, 14497
        • Rekrutacyjny
        • Research Site
  • Kostaryka
      • San José, Kostaryka
        • Rekrutacyjny
        • Research Site
  • Malezja
      • Kuala Lumpur, Malezja
        • Rekrutacyjny
        • Research Site
  • Meksyk
      • Iztapalapa, Meksyk
        • Rekrutacyjny
        • Research Site
      • Mexico City, Meksyk, 06720
        • Rekrutacyjny
        • Research Site
      • Mexico City, Meksyk
        • Rekrutacyjny
        • Research Site
      • México, Meksyk, 04530
        • Rekrutacyjny
        • Research Site
    • Guanajuato
      • León, Guanajuato, Meksyk, 37549
        • Rekrutacyjny
        • Research Site
  • Nigeria
      • Enugu, Nigeria, 400001
        • Rekrutacyjny
        • Research Site
      • Gwagwalada, Nigeria, 901002
        • Rekrutacyjny
        • Research Site
      • Kano, Nigeria, 700233
        • Rekrutacyjny
        • Research Site
  • Tajwan
      • Changhua, Tajwan, 500209
        • Rekrutacyjny
        • Research Site
      • Kaohsiung City, Tajwan, 81301
        • Rekrutacyjny
        • Research Site
      • Niaosong, Tajwan, 83301
        • Rekrutacyjny
        • Research Site
      • Taichung, Tajwan, 40447
        • Rekrutacyjny
        • Research Site
      • Taichung, Tajwan, 40705
        • Rekrutacyjny
        • Research Site
      • Taichung, Tajwan
        • Rekrutacyjny
        • Research Site
      • Tainan, Tajwan, 704
        • Rekrutacyjny
        • Research Site
      • Taipei, Tajwan
        • Rekrutacyjny
        • Research Site
      • Taoyuan City, Tajwan, 33305
        • Rekrutacyjny
        • Research Site
  • Ukraina
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraina, 49005
        • Rekrutacyjny
        • Research Site
    • Kharkiv Oblast
      • Kharkiv, Kharkiv Oblast, Ukraina, 61039
        • Rekrutacyjny
        • Research Site
      • Kharkiv, Kharkiv Oblast, Ukraina
        • Rekrutacyjny
        • Research Site
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ukraina, 3039
        • Rekrutacyjny
        • Research Site
      • Kyiv, Kyiv Oblast, Ukraina, 4050
        • Rekrutacyjny
        • Research Site
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraina, 21000
        • Rekrutacyjny
        • Research Site
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraina, 43024
        • Rekrutacyjny
        • Research Site
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraina, 88000
        • Rekrutacyjny
        • Research Site
    • Zaporizhzhia Oblast
      • Zaporizhzhya, Zaporizhzhia Oblast, Ukraina, 69035
        • Rekrutacyjny
        • Research Site
  • Zjednoczone Emiraty Arabskie
      • Sharjah city, Zjednoczone Emiraty Arabskie
        • Rekrutacyjny
        • Research Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Dorośli z cukrzycą typu 2, nadciśnieniem, niewydolnością serca i/lub przewlekłą chorobą nerek

Opis

Kryteria przyjęcia:

  1. Mając ukończone 18 lat
  2. Cukrzyca typu 2, nadciśnienie, niewydolność serca i/lub przewlekła choroba nerek
  3. Wyrażenie pisemnej świadomej zgody na udział w rejestrze

Kryteria wyłączenia:

  1. Zagrażająca życiu choroba współistniejąca z oczekiwaną długością życia poniżej 1 roku
  2. Uczestnictwo w badaniu interwencyjnym wymagającym świadomej zgody

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Inny
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / Kohorta
T2DM Cohort
Patients with T2DM as enrollment motif or T2DM as comorbidity
HTN Cohort
Patients with HTN as enrollment motif or HTN as comorbidity
CKD Cohort
Patients with CKD as enrollment motif or CKD as comorbidity
HF Cohort
Patients with HF as enrollment motif or HF as comorbidity

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
1. Age of particpants
Ramy czasowe: At Baseline
Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
At Baseline
2. Percentage of Participants by Sex
Ramy czasowe: At baseline
Distribution of participants by sex (male/female) reported as counts and percentages.
At baseline
3. Percentage of Participants by Ethnicity
Ramy czasowe: At Baseline
Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
At Baseline
4. Percentage of Participants by Education Level
Ramy czasowe: At Baseline
Distribution of participants by education level reported as counts and percentages for each education category.
At Baseline
5. Percentage of Participants by Marital Status
Ramy czasowe: At Baseline
Distribution of participants by marital status reported as counts and percentages for each marital status category.
At Baseline
6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease
Ramy czasowe: At Baseline
Percentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.
At Baseline
7.Percentage of Participants by Physical Activity Level
Ramy czasowe: At Baseline
Distribution of participants by physical activity level category reported as counts and percentages.
At Baseline
8. Percentage of Participants by Smoking Status
Ramy czasowe: At Baseline
Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
At Baseline
9. Percentage of Participants by Alcohol Consumption
Ramy czasowe: At Baseline
Distribution of participants by alcohol consumption category reported as counts and percentages.
At Baseline
10. Body Weight of Participants
Ramy czasowe: At Baseline
Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
At Baseline
11. Height of Participants
Ramy czasowe: At Baseline
Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
At Baseline
12. Body Mass Index (BMI) of Participants
Ramy czasowe: At Baseline
Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
At Baseline
13. Waist Circumference of Participants
Ramy czasowe: At Baseline
Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
At Baseline
14. Waist-to-Hip Ratio of Participants
Ramy czasowe: At Baseline
Waist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
At Baseline
15. Waist-to-Height Ratio of Participants
Ramy czasowe: At Baseline
Waist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
At Baseline
16. Percentage of Participants by Cardiac and Renal Functional Measurements Category
Ramy czasowe: At Baseline
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
At Baseline
17. Primary Disease Duration
Ramy czasowe: At Baseline
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.
At Baseline
18. Percentage of Participants by Number and Types of Comorbidities
Ramy czasowe: At Baseline
Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
At Baseline
19. Percentage of Participants by NYHA Functional Class
Ramy czasowe: 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
20. Percentage of Participants by Heart Failure Phenotype
Ramy czasowe: 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
21. Percentage of Participants by Heart Failure Etiology
Ramy czasowe: At Baseline
Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
At Baseline
22. Percentage of Participants by CKD Etiology
Ramy czasowe: At Baseline
Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
At Baseline
23. Percentage of Participants by Hypertension Stage
Ramy czasowe: At Baseline
Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
At Baseline
24. Percentage of Participants by Secondary Hypertension Etiology
Ramy czasowe: At Baseline
Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
At Baseline
25. Office Systolic and Diastolic Blood Pressure
Ramy czasowe: At Baseline
Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
At Baseline
26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values
Ramy czasowe: 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
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
Ramy czasowe: 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
28. Blood HbA1c
Ramy czasowe: Average of 3 years
HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
Average of 3 years
29. Fasting Glucose
Ramy czasowe: Average of 3 years
Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
Average of 3 years
30. Lipid Profile Testing
Ramy czasowe: 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
Average of 3 years
31. Serum Creatinine
Ramy czasowe: Average of 3 years
Serum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
Average of 3 years
32. Estimated Glomerular Filtration Rate (eGFR)
Ramy czasowe: 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.
Average of 3 years
33. Urine Albumin-to-Creatinine Ratio (UACR)
Ramy czasowe: Average of 3 years
Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
Average of 3 years
34. Serum Electrolyte Values
Ramy czasowe: 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.
Avergae of 3 years
35. Frequency of HbA1c Testing
Ramy czasowe: Average of 3 years
Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
36. Frequency of Fasting Glucose Testing
Ramy czasowe: Average of 3 years
Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
37. Frequency of Lipid Profile Testing
Ramy czasowe: 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.
Average of 3 years
38. Frequency of Serum Creatinine Testing
Ramy czasowe: Average of 3 years
Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
39. Frequency of eGFR Assessment
Ramy czasowe: 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
40. Frequency of Urine Albumin-to-Creatinine Ratio Testing
Ramy czasowe: 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
41. Echocardiography
Ramy czasowe: Average of 3 years
Frequency of echocardiography abnormalities reported as counts and percentages
Average of 3 years
42. Electrocardiogram (ECG)
Ramy czasowe: Average of 3 years
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
Average of 3 years
43. Participants Receiving Dietary Modification Counseling
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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%)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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%
Ramy czasowe: 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%
Ramy czasowe: 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%
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Śledczy

  • Dyrektor Studium: Hardik Vasnawala, MD, AstraZeneca
  • Dyrektor Studium: Isidro Villanueva, MD, AstraZeneca
  • Dyrektor Studium: Ahmed Hadaoui, PharmD, AstraZeneca

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 lutego 2018

Zakończenie podstawowe (Szacowany)

31 grudnia 2030

Ukończenie studiów (Szacowany)

31 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2018

Pierwszy wysłany (Rzeczywisty)

8 czerwca 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D1690R00044

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Wykwalifikowani badacze mogą poprosić o dostęp do anonimowych danych na poziomie poszczególnych pacjentów z grupy firm AstraZeneca sponsorujących badania kliniczne za pośrednictwem portalu wniosków. Wszystkie wnioski zostaną ocenione zgodnie z zobowiązaniem AZ do ujawnienia:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Tak, wskazuje, że AZ akceptuje prośby o IPD, ale nie oznacza to, że wszystkie prośby zostaną udostępnione.

Ramy czasowe udostępniania IPD

AstraZeneca zapewni lub przekroczy dostępność danych zgodnie ze zobowiązaniami podjętymi w ramach zasad udostępniania danych EFPIA Pharma. Szczegółowe informacje na temat naszych terminów można znaleźć w naszym zobowiązaniu do ujawniania informacji na stronie https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kryteria dostępu do udostępniania IPD

Gdy prośba zostanie zatwierdzona, AstraZeneca zapewni dostęp do zanonimizowanych danych na poziomie indywidualnego pacjenta w zatwierdzonym sponsorowanym narzędziu. Podpisana umowa o udostępnianiu danych (niepodlegająca negocjacjom umowa dla osób udostępniających dane) musi być podpisana przed uzyskaniem dostępu do żądanych informacji. Ponadto wszyscy użytkownicy będą musieli zaakceptować warunki SAS MSE, aby uzyskać dostęp. Aby uzyskać dodatkowe informacje, zapoznaj się z Oświadczeniami o ujawnieniu pod adresem https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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