Statins in Children With Type 1 Diabetes and Hypercholesterolemia
This study is currently recruiting participants.
Verified May 2013 by Nemours Children's Clinic
Sponsor:
Nemours Children's Clinic
Collaborators:
Pfizer
Medtronic
Quest Diagnostics
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01236365
First received: November 2, 2010
Last updated: May 19, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Insulin-Dependent Hypercholesterolemia |
Drug: Atorvastatin Drug: Atorvastatin Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
Further study details as provided by Nemours Children's Clinic:
Primary Outcome Measures:
- To investigate if the use of statins in children with type 1 DM is safe, improves measures of LDL-C and decreases the concentration of inflammatory markers. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]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 LCL-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.
Secondary Outcome Measures:
- To characterize the relationship between glycemic variability- measured by the mean amplitude of glycemic excursion with continuous glucose monitoring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]At randomization, 3 and 6 months a CGM (IPro®, Medtronic Minimed) will be worn blindly for 6d to assess glucose variability to correlate mean amplitude of glycemic excursions (MAGE) with changes in Lp particles and hsCRP.
- Investigate gene expression and concentration of key molecules that participate in the inflammatory process and arterial plaque formation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]We will restrict participation in protocol #2 to those with T1DM for >3 years and a HbA1C >8% using a stratified balanced randomization. Blood will be withdrawn for a special genetic test. Age-matched, non-diabetic healthy controls will be recruited for comparison.
- Measure subclinical atherosclerosis and vascular stiffness with the use of abdominal aortic MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]T1DM patients will have an MRI scan of the abdominal aorta using an image acquisition protocol to measure subclinical atherosclerosis and arterial stiffness. Subjects will be rescanned at the conclusion of the 6 month trial. A group of healthy, non diabetic age-matched controls will be scanned as well.
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Atorvastatin |
Drug: Atorvastatin
10 or 20 mg daily
Other Name: Lipitor
|
| Placebo Comparator: Placebo |
Drug: Atorvastatin Placebo
10 or 20 mg daily
|
Eligibility| Ages Eligible for Study: | 10 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236365
Contacts
| Contact: Kaitlin McCann, PNP | 904-697-3988 | kmccann@nemours.org |
Locations
| United States, Delaware | |
| Alfred I duPont Hospital | Recruiting |
| Wilmington, Delaware, United States | |
| Contact: Carol Prospero 302-651-6686 cprosper@nemours.org | |
| Sub-Investigator: Samuel Gidding, MD | |
| Sub-Investigator: Michael McCulloch, MD | |
| Sub-Investigator: Robert Mason, PhD | |
| United States, Florida | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Kaitlin McCann, PNP 904-697-3988 kmccann@nemours.org | |
| Principal Investigator: Nelly Mauras, MD | |
| Sub-Investigator: Atilio Canas, MD | |
| Nemours Children's Clinic | Recruiting |
| Orlando, Florida, United States | |
| Contact: Ann Powell, RN 407-650-7523 apowell@nemours.org | |
| Sub-Investigator: Martha Taboada, MD | |
| Nemours Children's Clinic | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Elise Williams, RN 850-473-4556 elwillia@nemours.org | |
| Sub-Investigator: Jennifer Bell, MD | |
| United States, Pennsylvania | |
| Nemours Children's Clinic-Jefferson | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Karen Kowal, PA 215-955-1648 kkowal@nemours.org | |
| Sub-Investigator: Judith Ross, MD | |
Sponsors and Collaborators
Nemours Children's Clinic
Pfizer
Medtronic
Quest Diagnostics
Investigators
| Principal Investigator: | Nelly Mauras, MD | Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207 |
More Information
No publications provided
| Responsible Party: | Nelly Mauras, Chief, Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT01236365 History of Changes |
| Other Study ID Numbers: | IRB# 185500 |
| Study First Received: | November 2, 2010 |
| Last Updated: | May 19, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Nemours Children's Clinic:
|
Statins Type 1 diabetes Children Hypercholesterolemia Lipoproteins C reactive protein |
Continuous glucose monitors Adolescence Abdominal magnetic resonance imaging Toll like receptors Receptors of advanced glycation end products Nutrition |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Hypercholesterolemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013