atorvastatin
Drug10 or 20 mg daily
Other names: Lipitor
NCT Number: NCT01236365
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.
Looking for future studies?
Notify Me10 year–20 year
All sexes
Interventional
Phase 3
Alfred I duPont Hospital, Wilmington, Delaware, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Project 1
Inclusion criteria
Projects 2 and 3
Exclusion criteria
Projects 1,2 and 3
10 or 20 mg daily
Other names: Lipitor
10 or 20 mg daily
Time frame: Randomization and 6 months
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.
Time frame: Randomization and 6 months
To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.
Time frame: Randomization and 6 months
Mean amplitude of glycemic excursion (MAGE) with continuous glucose monitoring (CGM - IPro®, Medtronic Minimed) worn blindly for 6d to assess glucose variability
Time frame: Randomization and 6 months
Receptor for Advanced Glycation End Products
Time frame: Randomization
Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI
Nemours Children's Clinic
Other
Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00690066
Autoimmune Diseases, Diabetes Mellitus
Birmingham, Alabama, United States
View Trial DetailsNCT05168657
Autoimmune Diabetes, Autoimmune Diseases
Aurora, Colorado, United States
View Trial DetailsNCT02814838
Autoimmune Diseases, Diabetes Mellitus
Brussels, Belgium
View Trial DetailsNCT00357890
Autoimmune Diseases, Diabetes Mellitus
Jacksonville, Florida, United States
View Trial Details