Statins in Children With Type 1 Diabetes and Hypercholesterolemia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-11-30

Brief Summary

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Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due to chronic increase in the blood sugars and inflammation. If there is also increased in cholesterol, it creates a highly abnormal environment not fully corrected by improved control of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention and treatment, compelling in children. This grant proposal encompasses 3 separate, yet interrelated projects addressing different aspects of CVD risk in children with T1DM. Project #1: a randomized controlled trial on the safety and efficacy of a class of drugs called "statins", which lower bad cholesterol in the body, in children with diabetes and elevated bad cholesterol. We will measure changes in concentration of blood inflammatory markers and for the 1st time, correlate levels of these markers with changes in blood sugar as measured by continuous glucose sensors, instruments that measure the blood sugar continuously through a small needle under the skin. Project #2: is a laboratory study to investigate the genetics and concentration of key molecules that participate in the inflammatory cascade and atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will be compared with those in healthy controls for the 1st time. Project #3: examines the use of abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy age-matched controls. The results of these studies will likely provide important new data on the use of statins in children with diabetes.

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Detailed Description

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Conditions

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Diabetes Mellitus, Insulin-Dependent Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

10 or 20 mg daily

Placebo

Group Type PLACEBO_COMPARATOR

Atorvastatin Placebo

Intervention Type DRUG

10 or 20 mg daily

Interventions

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Atorvastatin

10 or 20 mg daily

Intervention Type DRUG

Atorvastatin Placebo

10 or 20 mg daily

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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Inclusion Criteria

* T1DM diagnosed clinically for \> 1 year
* any HbA1C
* on stable insulin therapy
* Ages: 10 - 20 years
* both genders
* BMI \< 85th percentile
* Fasting LDL-C\>100mg/dl
* Normal thyroid function

* T1DM diagnosed clinically for \> 3 year
* HbA1C \> 8%
* on stable insulin therapy
* Ages: 12- 20 years
* both genders
* BMI \< 85th percentile
* Fasting LDL-C\>100mg/dl
* Normal thyroid function

Exclusion Criteria

* Severe dyslipidemia (LDL-C \>160, TG \> 400 mg/dl)
* Smoking
* Pregnancy
* Current use of anti-inflammatory or immunomodulatory drugs, lipid lowering, antidiabetic drugs
* Patients with hypertension and/or microalbuminuria will be allowed using balanced randomization and standardized treatment

Minimum Eligible Age

10 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes