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

NCT00729365 | Terminated Phase 3 Results DMC

• 1 other identifier: 1U01DK071733-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

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 patients with Type 1 diabetes who have normal blood pressure and urine albumin levels.

Conditions

Type 1 Diabetes

Keywords

Urine albumin excretion rates; Nighttime and daytime blood pressure; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.

  at 3months and then every 6months during the 5years of the study

Secondary Outcomes (1)

• We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.

  year 1, 3, 5 and after the washout phase (5years and 1month)

Study Arms (3)

Dippers - Placebo Treated

PLACEBO COMPARATOR

Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.

Drug: Placebo

NonDippers - Placebo Treated

PLACEBO COMPARATOR

Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.

Drug: Placebo

NonDippers - Ramipril Treated

ACTIVE COMPARATOR

Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).

Drug: Ramipril

Interventions

Ramipril DRUG

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.

Also known as: ACE Inhibitor

NonDippers - Ramipril Treated

Placebo DRUG

Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group.

Dippers - Placebo Treated

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Juvenile Diabetes Research Foundation: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

University of Florida

Gainesville, Florida, 32611, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center, Endocrinology Section

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Related Publications (4)

• Lurbe E, Redon J, Kesani A, Pascual JM, Tacons J, Alvarez V, Batlle D. Increase in nocturnal blood pressure and progression to microalbuminuria in type 1 diabetes. N Engl J Med. 2002 Sep 12;347(11):797-805. doi: 10.1056/NEJMoa013410.

  PMID: 12226150 BACKGROUND

• Dolan E, Stanton A, Thijs L, Hinedi K, Atkins N, McClory S, Den Hond E, McCormack P, Staessen JA, O'Brien E. Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension. 2005 Jul;46(1):156-61. doi: 10.1161/01.HYP.0000170138.56903.7a. Epub 2005 Jun 6.

  PMID: 15939805 BACKGROUND

• Lurbe A, Redon J, Pascual JM, Tacons J, Alvarez V, Batlle DC. Altered blood pressure during sleep in normotensive subjects with type I diabetes. Hypertension. 1993 Feb;21(2):227-35. doi: 10.1161/01.hyp.21.2.227.

  PMID: 8428785 BACKGROUND

• Haller MJ, Stein J, Shuster J, Theriaque D, Silverstein J, Schatz DA, Earing MG, Lerman A, Mahmud FH. Peripheral artery tonometry demonstrates altered endothelial function in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):193-8. doi: 10.1111/j.1399-5448.2007.00246.x.

  PMID: 17659060 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Ramipril; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

The study was terminated prematurely because of new information from the literature from other studies showing that this study could not be successful. Only 59 patients were screened and consented and 46 were found acceptable who were randomized.

Results Point of Contact

• Title: Mark E. Molitch
• Organization: Northwestern University Feinberg School of Medicine

molitch@northwestern.edu

312 503-4130

Study Officials

• Mark E Molitch, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 17, 2015
• Results First Posted: January 9, 2015

Record last verified: 2015-02

Locations

US (6)