Statins in Children With Type 1 Diabetes and Hypercholesterolemia

NCT01236365

Last updated date
Study Location
Alfred I duPont Hospital
Wilmington, Delaware, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Insulin-Dependent Diabetes Mellitus, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-20 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

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Insulin-Dependent Diabetes Mellitus, HypercholesterolemiaStatins in Children With Type 1 Diabetes and Hypercholesterolemia
NCT01236365
  1. Wilmington, Delaware
  2. Jacksonville, Florida
  3. Orlando, Florida
  4. Pensacola, Florida
  5. Philadelphia, Pennsylvania
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Official Title  ICMJE Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Insulin-Dependent
  • Hypercholesterolemia
Intervention  ICMJE
  • Drug: Atorvastatin
    10 or 20 mg daily
    Other Name: Lipitor
  • Drug: Atorvastatin Placebo
    10 or 20 mg daily
Study Arms  ICMJE
  • Experimental: Atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Intervention: Drug: Atorvastatin Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2010)
80
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01236365
Other Study ID Numbers  ICMJE IRB# 185500
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nelly Mauras, Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE
  • Pfizer
  • Medtronic
  • Quest Diagnostics
Investigators  ICMJE
Principal Investigator:Nelly Mauras, MDNemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
PRS Account Nemours Children's Clinic
Verification Date June 2019

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