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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Juvenile Diabetes Research Foundation; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Ramipril

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.