Diabetes Mellitus, Insulin-DependentPhase 3NCT01236365
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
A Phase 3 study testing Atorvastatin in people with Diabetes Mellitus, Insulin-Dependent and Hypercholesterolemia, run by Nemours Children's Clinic at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent, Hypercholesterolemia
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2010to Nov 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- T1DM diagnosed clinically for > 1 year
- any HbA1C
- on stable insulin therapy
- Ages: 10 - 20 years
- both genders
- BMI < 85th percentile
Show all 16Show fewer
- Fasting LDL-C>100mg/dl
- Normal thyroid function
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Nemours Children's Clinic
Jacksonville, Florida, 32207
Nemours Children's Clinic
Orlando, Florida
Nemours Children's Clinic
Pensacola, Florida, 32504
Nemours Children's Clinic-Jefferson
Philadelphia, Pennsylvania, 19107
Alfred I duPont Hospital
Wilmington, Delaware
About this study
Official title: Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
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.
- Being tested
- Atorvastatin, Atorvastatin Placebo
- Keywords
- Type 1 diabetes, Children, Statins, Hypercholesterolemia, Lipoproteins, C reactive protein, Continuous glucose monitors, Adolescence, Abdominal magnetic resonance imaging, Toll like receptors, Receptors of advanced glycation end products, Nutrition
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
10 or 20 mg daily
Atorvastatin PlaceboDrug
10 or 20 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Not described Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Atorvastatin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C Levels Assessed at 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.
Measured: Randomization and 6 months
Hs-CRP Levels Assessed at Randomization and 6 Months
To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.
Measured: Randomization and 6 months
Secondary outcomes (3)
MAGE
Mean amplitude of glycemic excursion (MAGE) with continuous glucose monitoring (CGM - IPro®, Medtronic Minimed) worn blindly for 6d to assess glucose variability
Measured: Randomization and 6 months
RAGE
Receptor for Advanced Glycation End Products
Measured: Randomization and 6 months
Descending Aortic Strain
Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI
Measured: Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelly Mauras, Nemours Children's Clinic
- Investigators
- Nelly Mauras, MD, Principal investigator, Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236365
- Sponsor's protocol ID
- IRB# 185500
- Status last verified
- Jun 2019
- First submitted
- 2 Nov 2010
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Canas JA, Ross JL, Taboada MV, Sikes KM, Damaso LC, Hossain J, Caulfield MP, Gidding SS, Mauras N. A randomized, double blind, placebo-controlled pilot trial of the safety and efficacy of atorvastatin in children with elevated low-density lipoprotein cholesterol (LDL-C) and type 1 diabetes. Pediatr Diabetes. 2015 Mar;16(2):79-89. doi: 10.1111/pedi.12245. Epub 2014 Nov 22.
PubMed 25418907McCulloch MA, Mauras N, Canas JA, Hossain J, Sikes KM, Damaso LC, Redheuil A, Ross JL, Gidding SS. Magnetic resonance imaging measures of decreased aortic strain and distensibility are proportionate to insulin resistance in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2015 Mar;16(2):90-7. doi: 10.1111/pedi.12241. Epub 2014 Dec 18.
PubMed 25524487
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function
- ClinicalTrials.gov ID
- NCT01236365
- Acronym / sponsor ID
- IRB# 185500
- Keywords
- Type 1 diabetes, Children, Statins, Hypercholesterolemia, Lipoproteins, C reactive protein, Continuous glucose monitors, Adolescence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Pfizer, Medtronic, Quest Diagnostics-Nichols Insitute
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 21 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin |
| Placebo | Placebo comparator | Drug: Atorvastatin Placebo |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- T1DM diagnosed clinically for > 1 year
- any HbA1C
- on stable insulin therapy
- Ages: 10 - 20 years
- both genders
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor10 or 20 mg daily | Drug | Atorvastatin |
| Atorvastatin Placebo10 or 20 mg daily | Drug | Placebo |
Primary outcome
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.
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.
3 secondary outcomes
MAGE
Time frame: Randomization and 6 months
RAGE
Time frame: Randomization and 6 months
Descending Aortic Strain
Time frame: Randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25418907Canas JA, Ross JL, Taboada MV, Sikes KM, Damaso LC, Hossain J, Caulfield MP, Gidding SS, Mauras N. A randomized, double blind, placebo-controlled pilot trial of the safety and efficacy of atorvastatin in children with elevated low-density lipoprotein cholesterol (LDL-C) and type 1 diabetes. Pediatr Diabetes. 2015 Mar;16(2):79-89. doi: 10.1111/pedi.12245. Epub 2014 Nov 22.
- Results publication: PubMed 25524487McCulloch MA, Mauras N, Canas JA, Hossain J, Sikes KM, Damaso LC, Redheuil A, Ross JL, Gidding SS. Magnetic resonance imaging measures of decreased aortic strain and distensibility are proportionate to insulin resistance in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2015 Mar;16(2):90-7. doi: 10.1111/pedi.12241. Epub 2014 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Mauras, MD principal investigator
Nemours Children's Clinic 807 Children's Way Jacksonville, Florida 32207
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Diabetes Mellitus, Insulin-Dependent and Hypercholesterolemia, run by Nemours Children's Clinic at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C Levels Assessed at Randomization and 6 Months (time frame: Randomization and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.