- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
Florida
-
Gainesville, Florida, Stati Uniti, 32611
- University of Florida
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60612
- University of Illinois at Chicago
-
Chicago, Illinois, Stati Uniti, 60637
- University of Chicago
-
Chicago, Illinois, Stati Uniti, 60611
- Northwestern University Feinberg School of Medicine
-
Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center, Endocrinology Section
-
Maywood, Illinois, Stati Uniti, 60153
- Loyola University Chicago
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Dippers - Placebo Treated
Subjects with normal nighttime blood pressure profile that decreases at night (Dippers).
This group are all given placebo.
|
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.
|
Comparatore placebo: NonDippers - Placebo Treated
Subjects with nighttime blood pressure that does not drop during the night (non-dippers).
This group will be given placebo.
|
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.
|
Comparatore attivo: 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).
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.
Lasso di tempo: at 3months and then every 6months during the 5years of the study
|
at 3months and then every 6months during the 5years of the study
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.
Lasso di tempo: year 1, 3, 5 and after the washout phase (5years and 1month)
|
year 1, 3, 5 and after the washout phase (5years and 1month)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Mark E Molitch, MD, Professor of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie del sistema endocrino
- Diabete mellito
- Diabete mellito, tipo 1
- Meccanismi molecolari dell'azione farmacologica
- Agenti antipertensivi
- Inibitori enzimatici
- Inibitori della proteasi
- Ramipril
- Inibitori dell'enzima di conversione dell'angiotensina
Altri numeri di identificazione dello studio
- 1U01DK071733-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Diabete di tipo 1
-
AmgenCompletato
-
Paolo MilaniReclutamentoAmiloidosi | Amiloidosi cardiaca | ATTR Amiloidosi Wild TypeItalia
-
Steen Hvitfeldt PoulsenReclutamentoATTR Amiloidosi Wild TypeDanimarca
-
Oncology Institute of Southern SwitzerlandUniversity of Kiel; Ente Ospedaliero Cantonale, BellinzonaCompletato
-
Henan Cancer HospitalCompletatoCancro colorettale metastatico KRAS, NRAS e BRAF V600E wild-type
-
AmgenCompletatoCancro colorettale metastatico RAS wild-type
-
Austin Neuromuscular CenterAlnylam PharmaceuticalsReclutamentoPolineuropatie | Amiloidosi da transtiretina | Amiloidosi correlata alla transtiretina di tipo selvaggio (ATTR). | Amiloidosi cardiaca da transtiretina wild-type | Amiloidosi ATTR di tipo selvaggioStati Uniti
-
Denver Health and Hospital AuthorityIscrizione su invitoDisturbo evitante restrittivo dell'assunzione di cibo | Anoressia Nervosa, Binge Eating/Purging Type | ARFIDE | Tipo restrittivo di anoressia nervosaStati Uniti
-
Rosemary Claire RodenChildren's Miracle NetworkIscrizione su invitoBulimia nervosa | Comportamento impulsivo | Eliminazione (disturbi alimentari) | Problemi alimentari | Disturbi alimentari in adolescenza | Anoressia Nervosa/Bulimia | Anoressia in adolescenza | Anoressia Nervosa, Atipica | Anoressia Nervosa, Binge Eating/Purging TypeStati Uniti
-
Oxford Brookes UniversityUniversity of OxfordCompletatoAttività fisica | Salute mentale Benessere 1 | Funzione cognitiva 1, sociale | Academic Attainment | Fitness TestingRegno Unito