- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01557972
Long-term of 10 Years Results of a Prospective Longitudinal Study
Usefulness of Home Blood Pressure Measurement in the Morning in Type 2 Diabetic Patients : Long-term (10 Years) Results of a Prospective Longitudinal Study
Previous cross-sectional studies have demonstrated that blood pressure (BP) measurements at home (HBP) in the morning offer stronger predictive power for micro- and macrovascular complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure measurements (CBP) (Kamoi K et al, 2002-2003). Further, a prospective, longitudinal study for 6 years in patients with type 2 diabetes also demonstrated that control of wakening-up HBP provides the stronger predictive power for the outcomes than that of CBP did (Kamoi et al, 2010).
However, it is not clear to show which of BP measurement provides the stronger predictive power for outcomes by comparing cumulative events over a longer time than 6 years. Therefore, the investigators examined which of HBP or CBP provides the stronger predictive power for outcomes in addition of renal anemia reported previously over 10 years in the patients with type 2 diabetes.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Niigata
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Nagaoka, Niigata, Japan, 940-2085
- Nagaoka Red Cross Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- After a detailed baseline examination, 400 Japanese subjects with type 2 diabetes reported previously are followed up for all-cause mortality and morbidity.
Exclusion Criteria:
- Other than the above, patients judged inappropriate as the subjects of this study by the investigator
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
1. Morning HP and NT
Subjects based on HBP were divided into MH and MN patients
|
To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes
|
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2. Clinic HP and NT
Subjects based on CBP were divided into CH and CN patients
|
To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
To clarify which of HBP or CBP provides the stronger predictive power for the outcomes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Death
Tidsramme: Average time is 10 years
|
Number of participats not alive
|
Average time is 10 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Microvascular complications including renal anemia
Tidsramme: Average time is 10 years
|
Average time is 10 years
|
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Macrovascular complications
Tidsramme: Average time is 10 years
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Average time is 10 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kyuzi Kamoi, MD, Nagaoka Red Cross Hospital
Publikationer og nyttige links
Generelle publikationer
- Kamoi K, Miyakoshi M, Soda S, Kaneko S, Nakagawa O. Usefulness of home blood pressure measurement in the morning in type 2 diabetic patients. Diabetes Care. 2002 Dec;25(12):2218-23. doi: 10.2337/diacare.25.12.2218.
- Kamoi K, Imamura Y, Miyakoshi M, Kobayashi C. Usefulness of home blood pressure measurement in the morning in type 1 diabetic patients. Diabetes Care. 2003 Aug;26(8):2473-5. doi: 10.2337/diacare.26.8.2473. No abstract available.
- Kamoi K, Ito T, Miyakoshi M, Minagawa S. Usefulness of home blood pressure measurement in the morning in patients with type 2 diabetes: long-term results of a prospective longitudinal study. Clin Exp Hypertens. 2010 May;32(3):184-92. doi: 10.3109/10641960903254513.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5
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Kliniske forsøg med Type 2 diabetes mellitus
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Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi... og andre samarbejdspartnereIkke rekrutterer endnuType 2 diabetes | Diabetes mellitus type 2Tyrkiet (Türkiye)
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes mellitus | Type 2 diabetes | Type 2 diabetes
-
El Katib HospitalIkke rekrutterer endnuType 2 diabetes mellitus (T2DM)
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He Eye HospitalIkke rekrutterer endnu
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectRekrutteringType 2 diabetes mellitus (T2DM)Forenede Stater
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Global Institute of Stem Cell Therapy and ResearchIkke rekrutterer endnu
-
Daewoong Pharmaceutical Co. LTD.Ikke rekrutterer endnuT2DM (Type 2 Diabetes Mellitus)
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Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina