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NCT Number: NCT01236365

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 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.

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Key information

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alfred I duPont Hospital, Wilmington, Delaware, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

10 or 20 mg daily

Other names: Lipitor

Atorvastatin Placebo

Drug

10 or 20 mg daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Medtronic
  • Pfizer
  • Quest Diagnostics-Nichols Insitute

Registry information

Official study title

Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Nov 8, 2010
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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