Status:
TERMINATED
PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
13-50 years
Phase:
PHASE3
Brief 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 patien...
Detailed Description
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 nor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00729365
Start Date
July 1 2008
End Date
June 1 2010
Last Update
March 17 2015
Active Locations (6)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
Rush University Medical Center, Endocrinology Section
Chicago, Illinois, United States, 60612
4
University of Illinois at Chicago
Chicago, Illinois, United States, 60612