CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01236365
NCT01236365Phase 3Completed

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

Nemours Children's Clinic·interventional·Posted Nov 8, 2010·Updated Jun 25, 2019

In Brief

A Phase 3 clinical trial evaluating Atorvastatin and Atorvastatin Placebo for Diabetes Mellitus, Insulin-Dependent and Hypercholesterolemia. Completed, enrolled 42 participants across 5 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2010
Enrollment StartOct 1, 2010
Primary CompletionOct 1, 2013
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.7 years ago

Interventions

Atorvastatindrug

10 or 20 mg daily

Atorvastatin Placebodrug

10 or 20 mg daily