Statins in Children With Type 1 Diabetes and Hypercholesterolemia
1 other identifier
interventional
42
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2010
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 2, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
May 21, 2015
CompletedJune 25, 2019
June 1, 2019
3 years
November 2, 2010
December 29, 2014
June 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
LDL-C Levels Assessed at 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.
Randomization and 6 months
Hs-CRP Levels Assessed at Randomization and 6 Months
To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.
Randomization and 6 months
Secondary Outcomes (3)
MAGE
Randomization and 6 months
RAGE
Randomization and 6 months
Descending Aortic Strain
Randomization
Study Arms (2)
Atorvastatin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nemours Children's Cliniclead
- Pfizercollaborator
- Medtroniccollaborator
- Quest Diagnostics-Nichols Insitutecollaborator
Study Sites (5)
Alfred I duPont Hospital
Wilmington, Delaware, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Nemours Children's Clinic
Orlando, Florida, United States
Nemours Children's Clinic
Pensacola, Florida, 32504, United States
Nemours Children's Clinic-Jefferson
Philadelphia, Pennsylvania, 19107, United States
Related Publications (2)
Canas JA, Ross JL, Taboada MV, Sikes KM, Damaso LC, Hossain J, Caulfield MP, Gidding SS, Mauras N. A randomized, double blind, placebo-controlled pilot trial of the safety and efficacy of atorvastatin in children with elevated low-density lipoprotein cholesterol (LDL-C) and type 1 diabetes. Pediatr Diabetes. 2015 Mar;16(2):79-89. doi: 10.1111/pedi.12245. Epub 2014 Nov 22.
PMID: 25418907RESULTMcCulloch MA, Mauras N, Canas JA, Hossain J, Sikes KM, Damaso LC, Redheuil A, Ross JL, Gidding SS. Magnetic resonance imaging measures of decreased aortic strain and distensibility are proportionate to insulin resistance in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2015 Mar;16(2):90-7. doi: 10.1111/pedi.12241. Epub 2014 Dec 18.
PMID: 25524487RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nelly Mauras, MD
- Organization
- Nemours Children's Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Nelly Mauras, MD
Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Endocrinology, Diabetes & Metabolism
Study Record Dates
First Submitted
November 2, 2010
First Posted
November 8, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2013
Study Completion
November 1, 2014
Last Updated
June 25, 2019
Results First Posted
May 21, 2015
Record last verified: 2019-06