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Statins in Children With Type 1 Diabetes and Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT01236365
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : May 21, 2015
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Pfizer
Medtronic
Quest Diagnostics-Nichols Insitute
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Insulin-Dependent Hypercholesterolemia Drug: Atorvastatin Drug: Atorvastatin Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
Study Start Date : October 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Atorvastatin Drug: Atorvastatin
10 or 20 mg daily
Other Name: Lipitor
Placebo Comparator: Placebo Drug: Atorvastatin Placebo
10 or 20 mg daily


Outcome Measures
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Primary Outcome Measures :
  1. LDL-C Levels Assessed at Randomization and 6 Months [ 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.

  2. Hs-CRP Levels Assessed at Randomization and 6 Months [ 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.


Secondary Outcome Measures :
  1. MAGE [ 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

  2. RAGE [ Time Frame: Randomization and 6 months ]
    Receptor for Advanced Glycation End Products

  3. Descending Aortic Strain [ Time Frame: Randomization ]
    Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236365


Locations
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United States, Delaware
Alfred I duPont Hospital
Wilmington, Delaware, United States
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic
Orlando, Florida, United States
Nemours Children's Clinic
Pensacola, Florida, United States, 32504
United States, Pennsylvania
Nemours Children's Clinic-Jefferson
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Nemours Children's Clinic
Pfizer
Medtronic
Quest Diagnostics-Nichols Insitute
Investigators
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Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
More Information
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Publications of Results:

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Responsible Party: Nelly Mauras, Chief, Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01236365    
Other Study ID Numbers: IRB# 185500
First Posted: November 8, 2010    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: June 25, 2019
Last Verified: June 2019
Keywords provided by Nelly Mauras, Nemours Children's Clinic:
Type 1 diabetes
Children
Statins
Hypercholesterolemia
Lipoproteins
C reactive protein
 Continuous glucose monitors
Adolescence
Abdominal magnetic resonance imaging
Toll like receptors
Receptors of advanced glycation end products
Nutrition
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors