Title
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
Phase
Phase 3Lead Sponsor
Thomas Jefferson UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Diabetes Mellitus, Insulin-Dependent HypercholesterolemiaIntervention/Treatment
atorvastatin ...Study Participants
42Children 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.
10 or 20 mg daily
10 or 20 mg daily
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
| Event Type | Organ System | Event Term | Atorvastatin | Placebo |
|---|
To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C >100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.
To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.
Mean amplitude of glycemic excursion (MAGE) with continuous glucose monitoring (CGM - IPro®, Medtronic Minimed) worn blindly for 6d to assess glucose variability
Receptor for Advanced Glycation End Products
Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI
