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

2015年2月24日 更新者: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.

調査の概要

状態

終了しました

条件

詳細な説明

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.

研究の種類

介入

入学 (実際)

65

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

13年~50年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター: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.
プラセボコンパレーター: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.
アクティブコンパレータ: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.

他の名前:
  • ACE阻害剤

この研究は何を測定していますか?

主要な結果の測定

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

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Mark E Molitch, MD、Professor of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年7月1日

一次修了 (実際)

2010年6月1日

研究の完了 (実際)

2010年6月1日

試験登録日

最初に提出

2008年8月4日

QC基準を満たした最初の提出物

2008年8月6日

最初の投稿 (見積もり)

2008年8月7日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年3月17日

QC基準を満たした最後の更新が送信されました

2015年2月24日

最終確認日

2015年2月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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