PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Ramipril; Placebo; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Ramipril; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 13 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Urine albumin excretion rates; Nighttime and daytime blood pressure; Endothelial Dysfunction

Summary:

      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.
    

Eligibility criteria:

        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.