Statins in Children With Type 1 Diabetes and Hypercholesterolemia



Status:Completed
Conditions:High Cholesterol, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:10 - 20
Updated:11/30/2013
Start Date:October 2010
End Date:December 2013
Contact:Kaitlin McCann, PNP
Email:kmccann@nemours.org
Phone:904-697-3988

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Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function


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.


Inclusion Criteria:Project 1

- 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

Inclusion Criteria:Projects 2 and 3

- 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:Projects 1,2 and 3

- 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
We found this trial at
3
sites
Philadelphia, Pennsylvania 19107
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Wilmington, Delaware
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Wilmington, DE
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