Status:
COMPLETED
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Pfizer
Medtronic
Conditions:
Diabetes Mellitus, Insulin-Dependent
Hypercholesterolemia
Eligibility:
All Genders
10-20 years
Phase:
PHASE3
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 cre...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01236365
Start Date
October 1 2010
End Date
November 1 2014
Last Update
June 25 2019
Active Locations (5)
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1
Alfred I duPont Hospital
Wilmington, Delaware, United States
2
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
3
Nemours Children's Clinic
Orlando, Florida, United States
4
Nemours Children's Clinic
Pensacola, Florida, United States, 32504