Evidence map›Paper›PMID 25418907›Full record

Trial reportPediatric diabetes2015

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.

Jose A Canas, Judith L Ross, Martha V Taboada, Kaitlin M Sikes, Ligeia C Damaso, Jobayer Hossain, Michael P Caulfield, Samuel S Gidding, Nelly Mauras

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric diabetes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01236365. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01236365 phase3completed

Statins in Children With Type 1 Diabetes: Effects on Metabolism, Inflammation and Endothelial Function

Ran2010Enrolled42Registered outcomes5Posted comparisons3ConditionsDiabetes Mellitus, Insulin-Dependent, HypercholesterolemiaArmsAtorvastatin, Atorvastatin Placebo
PMID 25524487other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Review
  7. Statins-Their Effect on Lipoprotein(a) Levels.Reviews in cardiovascular medicine · 2025
    Review
  8. Review
  9. Article
  10. Medication-induced hyperglycemia: pediatric perspective.BMJ open diabetes research & care · 2020
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Jose A CanasPediatric Endocrinology, Diabetes & Metabolism, Nemours Children's Clinic, Jacksonville, FL, USA.
Judith L Ross
Martha V Taboada
Kaitlin M Sikes
Ligeia C Damaso
Jobayer Hossain
Michael P Caulfield
Samuel S Gidding
Nelly Mauras
Alfred I. duPont Hospital for Children · USNemours Children's Clinic · USNemours Children's Clinic · USNemours Children’s Clinic · USQuest Diagnostics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren with type 1 diabetes (T1D) and elevated LDL-C have an increased risk for cardiovascular disease, a process that can begin in childhood.

objectiveTo assess the safety and efficacy of atorvastatin improving lipid profiles in children with T1D and elevated LDL-C. SUBJECTS: Sixty children (31M/29F) with T1D, mean age: 15 ± 0.3 yr, mean diabetes duration: 6.8 ± 0.5 yr, HbA(1c) : 8.8 ± 0.2%, with mean LDL-C 124 ± 4.0mg/dl were recruited.

methodsAfter a 3-month run-in period, subjects were randomized double-blindly to atorvastatin or placebo for 6 months. Lipoprotein subfractions were measured by ion mobility and glucose control by HbA1C; continuous glucose monitors were worn quarterly.

resultsAfter a run-in period, 42 subjects were randomized. There were decreases in total cholesterol (-21%), LDL-C (-32%), non-HDL-C (-31%) and apoB (-26%) in the atorvastatin group versus placebo (p < 0.001). Lipoprotein subparticles (LDL-large 1 and 2A, IDL-large and small, VLDL- medium and small) decreased with statins (p < 0.03 all). Insulin sensitivity scores remained constant in both groups and correlated inversely with apoB (r = -0.312 p = 0.039) and small LDL 3A (r = -0.404 p = 0.007). One subject had asymptomatic elevation of creatinine kinase which normalized after atorvastatin discontinuation.

conclusionsAtorvastatin lowered LDL-C, apoB, and atherogenic lipoprotein subparticles in children with T1D and elevated LDL-C without worsening insulin resistance. The drug was well tolerated and safe. Long-term studies would provide better insight on the impact of these interventions in the development of cardiovascular disease in children with diabetes.

Indexed as

AdolescentAtorvastatinChildCholesterol, LDLCombined Modality TherapyDiabetes Mellitus, Type 1Diet, DiabeticDiet, Fat-RestrictedDouble-Blind MethodDrug MonitoringExerciseFemaleGlycated HemoglobinHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsAtorvastatinCholesterol, LDLGlycated Hemoglobinhemoglobin A1c protein, humanHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsInsulinPyrrolesAdolescentsCardiovascular DiseaseHMG-CoAStatins

Identifiers

PMID25418907
OpenAlexW2150948948

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.