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Statins in Children With Type 1 Diabetes and Hypercholesterolemia

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Medtronic
Quest Diagnostics
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01236365
First received: November 2, 2010
Last updated: December 19, 2013
Last verified: December 2013

November 2, 2010
December 19, 2013
October 2010
May 2013   (final data collection date for primary outcome measure)
To investigate if the use of statins in children with type 1 DM is safe, improves measures of LDL-C and decreases the concentration of inflammatory markers. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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 LCL-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 At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.
Same as current
Complete list of historical versions of study NCT01236365 on ClinicalTrials.gov Archive Site
  • To characterize the relationship between glycemic variability- measured by the mean amplitude of glycemic excursion with continuous glucose monitoring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At randomization, 3 and 6 months a CGM (IPro®, Medtronic Minimed) will be worn blindly for 6d to assess glucose variability to correlate mean amplitude of glycemic excursions (MAGE) with changes in Lp particles and hsCRP.
  • Investigate gene expression and concentration of key molecules that participate in the inflammatory process and arterial plaque formation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will restrict participation in protocol #2 to those with T1DM for >3 years and a HbA1C >8% using a stratified balanced randomization. Blood will be withdrawn for a special genetic test. Age-matched, non-diabetic healthy controls will be recruited for comparison.
  • Measure subclinical atherosclerosis and vascular stiffness with the use of abdominal aortic MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    T1DM patients will have an MRI scan of the abdominal aorta using an image acquisition protocol to measure subclinical atherosclerosis and arterial stiffness. Subjects will be rescanned at the conclusion of the 6 month trial. A group of healthy, non diabetic age-matched controls will be scanned as well.
  • To characterize the relationship between glycemic variability- measured by the mean amplitude of glycmemic excursion with continuous glucose monitoring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At randomization, 3 and 6 months a CGM (IPro®, Medtronic Minimed) will be worn blindly for 6d to assess glucose variability to correlate mean amplitude of glycemic excursions (MAGE) with changes in Lp particles and hsCRP.
  • Investigate gene expression and concentration of key molecules that participate in the inflammatory process and arterial plaque formation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will restrict participation in protocol #2 to those with T1DM for >3 years and a HbA1C >8% using a stratified balanced randomization. Blood will be withdrawn for a special genetic test. Age-matched, non-diabetic healthy controls will be recruited for comparison.
  • Measure subclinical atherosclerosis and vascular stiffness with the use of abdominal aortic MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    T1DM patients will have an MRI scan of the abdominal aorta using an image acquisition protocol to measure subclinical atherosclerosis and arterial stiffness. Subjects will be rescanned at the conclusion of the 6 month trial. A group of healthy, non diabetic age-matched controls will be scanned as well.
Not Provided
Not Provided
 
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Insulin-Dependent
  • Hypercholesterolemia
  • Drug: Atorvastatin
    10 or 20 mg daily
    Other Name: Lipitor
  • Drug: Atorvastatin Placebo
    10 or 20 mg daily
  • Experimental: Atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Intervention: Drug: Atorvastatin Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
10 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01236365
IRB# 185500
Yes
Nelly Mauras, Nemours Children's Clinic
Nemours Children's Clinic
  • Pfizer
  • Medtronic
  • Quest Diagnostics
Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
Nemours Children's Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP