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PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease) (PREVENTKD)

24. februar 2015 opdateret af: Mark Molitch, Northwestern University

Nocturnal Hypertension and Prevention of Microalbuminuria in Type 1 Diabetes

The purpose of this study is to determine if the early treatment with a blood pressure medication (an ACE Inhibitor) can prevent or delay the development of kidney disease (microalbuminuria) in patients with Type 1 diabetes who have normal blood pressure and urine albumin levels.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Florida
      • Gainesville, Florida, Forenede Stater, 32611
        • University of Florida
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center, Endocrinology Section
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Chicago

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år til 50 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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.
Placebo komparator: 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.
Aktiv 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).

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.

Andre navne:
  • ACE-hæmmer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.
Tidsramme: at 3months and then every 6months during the 5years of the study
at 3months and then every 6months during the 5years of the study

Sekundære resultatmål

Resultatmål
Tidsramme
We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.
Tidsramme: year 1, 3, 5 and after the washout phase (5years and 1month)
year 1, 3, 5 and after the washout phase (5years and 1month)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mark E Molitch, MD, Professor of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

4. august 2008

Først indsendt, der opfyldte QC-kriterier

6. august 2008

Først opslået (Skøn)

7. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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