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

2015년 2월 24일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

65

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

13년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.
위약 비교기: 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.
활성 비교기: 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.

다른 이름들:
  • ACE 억제제

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Mark E Molitch, MD, Professor of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 7월 1일

기본 완료 (실제)

2010년 6월 1일

연구 완료 (실제)

2010년 6월 1일

연구 등록 날짜

최초 제출

2008년 8월 4일

QC 기준을 충족하는 최초 제출

2008년 8월 6일

처음 게시됨 (추정)

2008년 8월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 3월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 2월 24일

마지막으로 확인됨

2015년 2월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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