Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

NCT ID: NCT00130481

Last Updated: 2012-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-04-30

Brief Summary

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The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes. Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months.

Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin 20 mg daily for 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year
* Age 10-18 years.

Exclusion Criteria

* Cardiovascular disease (CVD)
* Liver disease
* Pregnancy
* Use of cholesterol or triglyceride lowering drugs
* Perceived inability to comply with the study protocol
* Endocrinopathy other than diabetes
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Haller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Haller MJ, Samyn M, Nichols WW, Brusko T, Wasserfall C, Schwartz RF, Atkinson M, Shuster JJ, Pierce GL, Silverstein JH. Radial artery tonometry demonstrates arterial stiffness in children with type 1 diabetes. Diabetes Care. 2004 Dec;27(12):2911-7. doi: 10.2337/diacare.27.12.2911.

Reference Type BACKGROUND
PMID: 15562206 (View on PubMed)

Haller MJ, Stein JM, Shuster JJ, Theriaque D, Samyn MM, Pepine C, Silverstein JH. Pediatric Atorvastatin in Diabetes Trial (PADIT): a pilot study to determine the effect of atorvastatin on arterial stiffness and endothelial function in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2009 Jan;22(1):65-8. doi: 10.1515/jpem.2009.22.1.65.

Reference Type DERIVED
PMID: 19344076 (View on PubMed)

Other Identifiers

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GCRC M-01 RR 000082

Identifier Type: -

Identifier Source: secondary_id

Pfizer 2004-0926

Identifier Type: -

Identifier Source: secondary_id

DARE 187

Identifier Type: -

Identifier Source: secondary_id

576-2004

Identifier Type: -

Identifier Source: org_study_id

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