Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01236365 · ClinicalTrials.gov registry record · Phase 3
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
A Phase 3 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT01236365 is a Phase 3 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 42 participants.
The verdict
NCT01236365, a Phase 3 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study 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.
Interventions
- DRUG Atorvastatin
- DRUG Atorvastatin Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01236365
The ClinicalTrials.gov registry entry for NCT01236365 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atorvastatin is the first listed.
NCT01236365 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01236365 about?
NCT01236365 is a clinical study titled "Statins in Children With Type 1 Diabetes and Hypercholesterolemia". 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 ...
What is the current status of trial NCT01236365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2010-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01236365?
The interventions under investigation include: Atorvastatin (DRUG), Atorvastatin Placebo (DRUG).
Who is sponsoring clinical trial NCT01236365?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.