Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Condition: Diabetes Mellitus, Insulin-Dependent; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypercholesterolemia
Intervention: Atorvastatin; Atorvastatin Placebo
Intervention description: 10 or 20 mg daily; 10 or 20 mg daily
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 10 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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

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.
    

Eligibility 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