Phase 3
N=42
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Diabetes Mellitus, Insulin-Dependent · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01236365 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
May 2015
Primary outcome: Primary: LDL-C Levels Assessed at Randomization and 6 Months — 128; 87; 126; 133 mg/dL — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atorvastatin (Drug); Atorvastatin Placebo (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL-C Levels Assessed at Randomization and 6 Months |
128; 87; 126; 133 | <0.0001 sig |
| PRIMARY Hs-CRP Levels Assessed at Randomization and 6 Months |
0.363; 0.419; 0.248; 0.446 | 0.913 |
| SECONDARY MAGE |
150; 156; 156; 152 | — |
| SECONDARY RAGE |
49; 35; 50; 58 | — |
| SECONDARY Descending Aortic Strain |
27.2; 29 | 0.09 |
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 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 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
Data sourced from ClinicalTrials.gov (NCT01236365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.