- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00729365
PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease) (PREVENTKD)
Nocturnal Hypertension and Prevention of Microalbuminuria in Type 1 Diabetes
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Only a fraction of persons with Type 1 diabetes (less than 40%) develop diabetic kidney disease (nephropathy). When the urinary albumin (a protein normally excreted in small amounts) is within the normal range, the prevalence of high blood pressure (hypertension) based on office blood pressure readings is very low. Many of these persons, however, develop nocturnal hypertension (high nighttime blood pressure) before the development of abnormally high urinary albumin excretion (a condition referred to as microalbuminuria). Currently, early treatment with medications called ACE inhibitors is only recommended after there is an indication of kidney damage, as reflected by the presence of microalbuminuria. Beginning ACE inhibitor therapy is currently not recommended prior to the development of microalbuminuria, unless patients have high blood pressure, because it would result in over-treatment of many people. By the time that microalbuminuria develops, however, kidney damage may be present and many patients will develop kidney disease. It would therefore be beneficial to identify those subjects who will develop microalbuminuria, so that treatment could be started early for those individuals. Persons who may go on to develop protein in their urine and eventual kidney disease perhaps could be identified on the basis of an abnormal fall (too little) in blood pressure at night. This pattern should not be confused with high blood pressure, but instead seen as an early indication present before the development of high blood pressure and microalbuminuria.
The purpose of the current study is therefore aimed at demonstrating that it is possible to prevent kidney disease in patients with type 1 diabetes and normal office blood pressure and urine protein excretion by selecting them on the basis of an abnormal fall in blood pressure at night. Moreover, this clinical trial will reveal the impact of long-term administration of an ACE inhibitor on nighttime blood pressure and also assess changes in the relative stiffness of blood vessels(endothelial dysfunction) in persons with type 1 diabetes over time.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32611
- University of Florida
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Stany Zjednoczone, 60637
- University of Chicago
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Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University Feinberg School of Medicine
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Chicago, Illinois, Stany Zjednoczone, 60612
- Rush University Medical Center, Endocrinology Section
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Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University Chicago
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Subjects with type 1 diabetes confirmed by C peptide measurements.
- Male and Female subjects of all races will be included in this study.
- Subjects age must be between 13 to 50 years
- Duration of the disease (from time of diagnosis of diabetes) must be between 5 to 28 years.
- Subjects must be normotensive defined as a systolic blood pressure of ≤ 130 mmHg and diastolic of ≤ 85 mmHg in subjects 18 and older and for children (ages 13-17) blood pressure will be in the normal range based on standard tables which takes in to account gender, height and age.
- The mean 24 blood pressure must meet the same criteria as the office blood pressures outlined above.
- Subject must have normoalbuminuria (UAE < 30 mg/24 hrs)
- If subject is a female she must not be breast-feeding, and not of child-bearing potential, defined as post-menopausal for at least 1 year or surgically sterile; if she is of child bearing potential, then she must be practicing one of the following methods of birth control: 1) condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), 2) contraceptives (oral or parenteral) initiated three months prior to study drug administration, 3) maintain a monogamous relationship with a vasectomized partner, or 4) total abstinence from sexual intercourse.
Exclusion Criteria:
- Type 2 diabetics and other types of diabetics such as those with maturity onset diabetes or the young (MODY) will be excluded on the basis of established clinical criteria.
- Subjects who have a history of hypertension or is taking any hypertensive medications.
- Females who are pregnant or express a desire to become pregnant during the study. Females who are breast-feeding. Refer to details in inclusion criteria above regarding females.
- Subjects who have a history of taking ACE inhibitors within the last six months or have a current indication for ACE inhibitor therapy.
- Subjects (18 years of age and over) with a current blood pressure above 130mmHg/85mmHg. Subjects (13-17 years of age) who do not meet the normal range based on the standard tables
- Subjects who are currently microalbuminuric i.e. 24hr albumin > 30mg
- Subjects who have participated in an interventional clinical trial involving ABPM 6 months prior to this study.
- Subjects that have a diagnosis of chronic atrial fibrillation.
- Subjects with a lifestyle that would disrupt normal circadian rhythm (i.e. night-shift workers).
- Subjects with a current serious co-morbid condition for which life expectancy is <2 years.
- Subjects with a history of non-compliance, or psychiatric disturbance that would preclude successful completion of the study.
- Inability to give informed consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Komparator placebo: Dippers - Placebo Treated
Subjects with normal nighttime blood pressure profile that decreases at night (Dippers).
This group are all given placebo.
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Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo.
Control group.
Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into the control group and given Placebo.
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Komparator placebo: NonDippers - Placebo Treated
Subjects with nighttime blood pressure that does not drop during the night (non-dippers).
This group will be given placebo.
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Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo.
Control group.
Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into the control group and given Placebo.
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Aktywny komparator: NonDippers - Ramipril Treated
Subjects with nighttime blood pressure that does not drop during the night (non-dippers).
This group will be given ACE inhibitor (study medication).
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ACE inhibitor known as Ramipril Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the "Non-Dippers" groups II and III will be randomized to receive either drug or placebo.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.
Ramy czasowe: at 3months and then every 6months during the 5years of the study
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at 3months and then every 6months during the 5years of the study
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.
Ramy czasowe: year 1, 3, 5 and after the washout phase (5years and 1month)
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year 1, 3, 5 and after the washout phase (5years and 1month)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Mark E Molitch, MD, Professor of Medicine
Publikacje i pomocne linki
Publikacje ogólne
- Haller MJ, Stein J, Shuster J, Theriaque D, Silverstein J, Schatz DA, Earing MG, Lerman A, Mahmud FH. Peripheral artery tonometry demonstrates altered endothelial function in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):193-8. doi: 10.1111/j.1399-5448.2007.00246.x.
- Dolan E, Stanton A, Thijs L, Hinedi K, Atkins N, McClory S, Den Hond E, McCormack P, Staessen JA, O'Brien E. Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension. 2005 Jul;46(1):156-61. doi: 10.1161/01.HYP.0000170138.56903.7a. Epub 2005 Jun 6.
- Lurbe E, Redon J, Kesani A, Pascual JM, Tacons J, Alvarez V, Batlle D. Increase in nocturnal blood pressure and progression to microalbuminuria in type 1 diabetes. N Engl J Med. 2002 Sep 12;347(11):797-805. doi: 10.1056/NEJMoa013410.
- Lurbe A, Redon J, Pascual JM, Tacons J, Alvarez V, Batlle DC. Altered blood pressure during sleep in normotensive subjects with type I diabetes. Hypertension. 1993 Feb;21(2):227-35. doi: 10.1161/01.hyp.21.2.227.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia metabolizmu glukozy
- Choroby metaboliczne
- Choroby układu odpornościowego
- Choroby Autoimmunologiczne
- Choroby układu hormonalnego
- Cukrzyca
- Cukrzyca typu 1
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwnadciśnieniowe
- Inhibitory enzymów
- Inhibitory proteazy
- Ramipryl
- Inhibitory konwertazy angiotensyny
Inne numery identyfikacyjne badania
- 1U01DK071733-01A1 (Grant/umowa NIH USA)
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 .
Badania kliniczne na Cukrzyca typu 1
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Leiden University Medical CenterZakończonyGruczolak przysadki | Guz przysadki | Diabetes Insipidus Cranial Type | Dokrewny; NiedobórHolandia
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National Center for Research Resources (NCRR)Northwestern UniversityZakończonyMoczówka prosta | Diabetes Insipidus, NeurohypophysealStany Zjednoczone
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Ferring PharmaceuticalsZakończonyCentralna moczówka prostaJaponia
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Universitair Ziekenhuis BrusselZakończonyNefrogenna moczówka prostaBelgia
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National Center for Research Resources (NCRR)Northwestern UniversityZakończonyDiabetes Insipidus, nefrogenny
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Oxford Brookes UniversityUniversity of OxfordZakończonyAktywność fizyczna | Zdrowie psychiczne Wellness 1 | Funkcja poznawcza 1, społeczna | Academic Attainment | Fitness TestingZjednoczone Królestwo
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Emory UniversityZakończony
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Elizabeth Austen LawsonJeszcze nie rekrutacjaCentralna moczówka prostaStany Zjednoczone
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University of Colorado, DenverUniversity of AarhusZakończonyNefrogenna moczówka prostaStany Zjednoczone, Dania
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Merck Sharp & Dohme LLCRekrutacyjnyNiedrobnokomórkowego raka płuca | Guzy lite | Zaprogramowana śmierć komórki-1 (PD1, PD-1) | Programowana śmierć komórki 1 Ligand 1 (PDL1, PD-L1) | Programowana śmierć komórki 1 Ligand 2 (PDL2, PD-L2)Japonia
Badania kliniczne na Placebo
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SamA Pharmaceutical Co., LtdNieznanyOstre zapalenie oskrzeli | Ostra infekcja górnych dróg oddechowychRepublika Korei
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National Institute on Drug Abuse (NIDA)ZakończonyUżywanie konopi indyjskichStany Zjednoczone
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyZakończonyMężczyźni z cukrzycą typu II (T2DM)Niemcy
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Heptares Therapeutics LimitedZakończonyFarmakokinetyka | Problemy z bezpieczeństwemZjednoczone Królestwo
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West Penn Allegheny Health SystemZakończonyAstma | Alergiczny nieżyt nosaStany Zjednoczone
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Soroka University Medical CenterZakończony
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Regado Biosciences, Inc.ZakończonyZdrowy ochotnikStany Zjednoczone
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Longeveron Inc.ZakończonyZespół niedorozwoju lewego sercaStany Zjednoczone
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ItalfarmacoZakończonyDystrofia mięśniowa BeckeraHolandia, Włochy